Project Management, System Engineering, Electrical Design, Software Design, Design Verification, DFX, Human Factors Engineering, Engineering, Design Research, Industrial Design, UI/UX, Mechanical Design, RF/Wireless Design, Optical Design, Prototyping, Design Transfer, Test Development, Packaging & Sterilization, Contract Manufacturing
Featured Listings
Latest Listings
duagon USA – medical grade computer boards and systems for healthcare applications
- 860 Penllyn Blue Bell Pike, Blue Bell, PA 19422
- 215-542-9575
- AS 9100ISO 9001
Invio Automation
- 16185 National Pkwy, Lansing, MI 48906
- 517-321-7700
- ISO 9001:2015
Laird Connectivity
- Akron, OH
- 301-434-7929
- ISO 17025ISO 9001
THRIVE
- 1000 Marietta St NW, Atlanta, GA 30318, Suite 290, Atlanta, GA 30318
- 404.228.7342
- ISO 9001:2015
DeepDyve Digital Library
- 633 Menlo Ave, Menlo Park, CA 94025, USA
- 650-562-7221
- ISO 7
Nordson EFD
- East Providence, RI, USA
- 800-556-3484
- ISO 9001:2015
Carlisle Medical Technologies
- 100 Tensolite Dr, St. Augustine, FL 32092, USA
- 1-833-Call4CMT
- AS 9100ISO 13485ISO 14000ISO 14001:2015ISO 9001
Integrated Computer Solutions
- 230 2nd Ave, Waltham, MA 02451, USA
- 617-621-0060
- ISO 13485
Hobson & Motzer
- 30 Airline Drive, Durham, CT 06422
- 860-349-1756
- ISO 13485ISO 9001
Optikos Corporation
- 107 Audubon Rd, Wakefield, MA 01880, USA
- +1 6173547557
- ISO 13485:2016ISO 9001:2015
Argon Medical Devices – Custom Product Solutions
- 1445 Flat Creek Rd, Athens, TX 75751, USA
- 1. 833.824.0608
- ISO 13485:2016
PSN Labs
- 5368 Kuhl Rd, Erie, PA 16510, USA
- 814-464-0790
- ISO 17025ISO 9001:2015
WESTPAK, Inc.
- 83 Great Oaks Blvd
- (800) 830-8021
- ISO 17025
Spectrum Solutions
- 12248 Lone Peak Parkway | Suite 106 | Draper, UT 84020
- 8015690465
- ISO 13485:2016
Natech Plastics – Custom Injection Molding
- 85 Remington Blvd, Ronkonkoma, NY 11779, USA
- 6315803506
- ISO 13485ISO 13485:2016ISO 13845ISO 9001ISO 9001:2015ISO Class 8
Steute Meditech, Inc.
- 901 Ethan Allen Hwy, Ridgefield, CT 06877, USA
- 2032446302
- ISO 13485:2016ISO 9001:2015
Ametek Engineered Medical Components
- 7800 Equitable Drive Suite 250 Eden Prairie, Minnesota 55344
- (612) 426-3555
- ISO 13485
Zeus
- 3737 Industrial Blvd, Orangeburg, SC, 29118
- (803) 268-9500
- ISO 13485:2003ISO 9001:2008
XL Precision Technologies Ltd
- 79 Sadler Forster Way, Teesside Industrial Estate, Stockton-on-Tees, UK, TS17 9JY
- (610) 350-6993
- ISO 13485
Ximedica
- 55 Dupont Drive, Providence, RI, 2907
- (401) 330-3136
- ISO 13485:2012
MedTech News
New skin-safe materials for additive manufacturing will advance medical device design
New materials open the applications for using 3D printing for personalized medical devices.
Read more
By Guillaume Bailliard, Formlabs
This is a skull with a cranial implant prototype designed by BTech Innovation. The long, curved part is an airway device designed by VIDA Medical Devices. The triangular part is a drug delivery device (inhaler) prototype designed by Sandoz Device Development Centre (formerly Coalesce). The larger threaded part is an arthroscopic cannula and the smaller threaded part is an interference screw. The parts were printed in BioMed Black Resin and BioMed White Resin. [Photo courtesy of Formlabs]
Additive manufacturing will make personalized medical devices affordable. As 3D printers have become more accessible and manufacturers innovate new materials for medical applications, the industry is delivering patient-specific orthotics, prosthetics, dental devices and more.But adoption has not y…
Medtronic faces a wait-and-see attitude from analysts
Medtronic (NYSE: MDT) + stock continues to decline today — a day after it underwhelmed The Street with its growth projection for its new fiscal year.
MDT shares were down more than 2% to $81.58 apiece by midday today — a day after the stock fell another 2% in value. Meanwhile, MassDevice’s MedTech 100 Index — as well as the S&P 500 — were up on hopes that President Joe Biden and House Speaker Kevin McCarthy are close to striking a debt ceiling deal.
For the fiscal year ending in April 2024, Medtronic expects 4–4.5% revenue growth. One analyst described the guidance as “worse (more conservative?) than we expected.” Company officials told analysts during yesterday’s earnings call that they wanted to be prudent. They said they’re seeking durable revenue growth.
Even as it divests some businesses and engages in significant cost reductions including layoffs, Medtronic is also boosting R&D sp…
The top cardiac care innovation news at Heart Rhythm 2023
The future of cardiac care was on display at the Heart Rhythm Society’s 2023 annual meeting.
Medical device companies showcased groundbreaking technologies at Heart Rhythm 2023, May 19-21 in New Orleans. The innovations presented during the event offer new avenues for diagnosis, treatment, and monitoring of cardiovascular conditions, providing hope for patients worldwide.
Boston Scientific, Abbott, Medtronic, Philips, and iRhythm unveiled advances that have the potential to revolutionize the field of cardiology and improve patient outcomes.
The cardiology devices showcased at the Heart Rhythm 2023 hold promise for the future of cardiovascular care. As these innovations continue to advance, they have the potential to significantly improve the lives of patients worldwide. Stay tuned as we delve deeper into the details of these groundbreaking technologies and their impact on the field of cardiology.
Get the full story on o…
Hemco offers VSE Balance Enclosure for critical procedures involving powders and liquids
NEWS RELEASE: VSE Balance Enclosure for critical procedures involving powders and liquids
Read more
The Hemco VSE Balance Enclosure [Image courtesy of Hemco]
The VSE is offered in 24”, 36” and 48” widths to accommodate an analytical balance and other small-scale lab processes.Constructed of chemical-resistant metal framing and 1/4” thick clear acrylic side panels and viewing sash. Efficient air flow design with airfoil and bypass directs contaminates to baffled exhaust thereby providing superior air flow and containment performance for user protection.
The viewing sash is angled 15 degrees for ease of viewing comfort with 8” reach-in opening height. Sash swings up to provide 20” of access opening. Two service ports are in lower right and left rear wall.
The ergonomic design provides added user comfort.
Call 816-796-2900, or visit HEMCO at www.HEMCOcorp.com/vse.html
The opinions expressed in t…
Siemens Healthineers plans new semiconductor factory for photon-counting CT scanner
Siemens Healthineers plans to build a new factory for cultivating crystals used in advanced computed tomography (CT) scanners.[Rendering courtesy of Siemens Healthineers]
Siemens Healthineers announced plans this week to build a factory in Germany for cultivating crystals used to make semiconductors for advanced computed tomography (CT) scanners.The medtech giant said its existing production facility in Japan is at capacity, and that the new fabrication plant (or “fab”) is scheduled to come online in 2026.
Previously: FDA updates medical device shortage list due to shipping delays and semiconductors
The 9,000-m² Forchheim fab will cost 80 million euros, Seimens said. The company has invested around half a billion euros in its Forcheim operations since 2019.
“We made a conscious decision in favor of the Forchheim site. Here we are building the world’s first photon-co…
Neuralink says FDA has OK’d a human trial
Neuralink says its brain-computer interface is fully implantable, cosmetically invisible, and designed to let a person control a computer or mobile device anywhere they go. [Image courtesy of Neuralink]Elon Musk’s Neuralink says the FDA has approved a first-in-human clinical trial for its brain-computer interface technology.
Read more
Neuralink said on Twitter yesterday:
“We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study!
This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our technology to help many people.
Recruitment is not yet open for our clinical trial. We’ll announce more information on this soon!”
FDA media relations could not be immediately reached for comment.
Citing anonymous current and former employees, Reuters has reported that the FDA previously rejec…
Fast Five: Medtronic’s nearly $740M acquisition, Boston Scientific bows out of an acquisition
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, May 26, 2023.
Fast Five by MassDevice · Medtronic’s nearly $740M acquisition, Boston Scientific bows out of an acquisitionMedtronic, as a leading medical device company, plays a significant role in the industry, and its stock performance is closely watched by investors and industry experts. The recent dip in Medtronic’s stock can be attributed to the company’s growth projections falling short of market expectations. Fast Five hosts Sean Whooley and Danielle Kirsh outline the company’s performance in the last quarter and what it anticipates for the future.
HeartBeam’s win of an AI-related patent for its handheld vector ECG (electrocardiogram) device highlights the company’s commitment to innovation and technological advancements in cardi…
CLN-619 antibody therapy offers a new hope for patients with advanced solid tumors
Illustration of Fragment Crystallizable (Fc)-mediated cytotoxicity boosting tumor cell destruction. It highlights the increased MICA-NKG2D interaction, enhancing NK cell/T cell activation, and shows the reduction of MICA/MICB decoy release, improving NKG2D functionality. [Image courtesy of Cullinan Oncology]
Boston-based Cullinan Oncology has unveiled data for its new monoclonal antibody therapy, CLN-619, ahead of the American Society of Clinical Oncology (ASCO) 2023 meeting scheduled for June 2–6 in Chicago. The drug could potentially offer a new treatment option for patients with advanced solid tumors.Dr. Judy Wang, Associate Director of Drug Development at the Florida Cancer Specialists and Research Institute, explained the science behind the therapy. “CLN-619 is a human IgG1 monoclonal antibody that binds to cell surface ligands called MICA and MICB. These new immune therapies are trying to overcome t…
Analysts still high on Insulet despite Medtronic’s EOFlow buy, stock market reaction
The Insulet Omnipod 5 (left) and the EOFlow EOPatch (right), just acquired by Medtronic.
Read more
Despite a negative reaction from investors following a major buy in the insulin delivery space, analysts still back Insulet (Nasdaq:PODD) stock to perform.
Shares of PODD fell throughout today after Medtronic (NYSE:MDT) announced a $738 million acquisition of EOFlow. Korea-based EOFlow develops the EOPatch, a tubless, wearable and fully disposable insulin delivery device. Insulet represents a market leader in that space with its own Omnipod patch pump platform. Omnipod 5 became the first available tubeless, wearable, automated insulin delivery system after the FDA cleared it in January 2022.
By mid-afternoon, shares of PODD fell 7.3% to $272.24 apiece. Tandem Diabetes Care, another competitor in the space, saw its shares go down 5.5% to $26.62 apiece..
In spite of the negative reaction by the markets, BTIG analysts Marie Thibault and Sam Eiber expect Insulet to maint…
The top cardiac care innovation news at Heart Rhythm 2023
The future of cardiac care was on display at the Heart Rhythm Society’s 2023 annual meeting.
Medical device companies showcased groundbreaking technologies at Heart Rhythm 2023, May 19-21 in New Orleans. The innovations presented during the event offer new avenues for diagnosis, treatment, and monitoring of cardiovascular conditions, providing hope for patients worldwide.
Boston Scientific, Abbott, Medtronic, Philips, and iRhythm unveiled advances that have the potential to revolutionize the field of cardiology and improve patient outcomes.
The cardiology devices showcased at the Heart Rhythm 2023 hold promise for the future of cardiovascular care. As these innovations continue to advance, they have the potential to significantly improve the lives of patients worldwide. Stay tuned as we delve deeper into the details of these groundbreaking technologies and their impact on the field of cardiology.
Here’s a roundup of Associate Editor Se…
FDA approves Zoll therapy for sleep apnea with MRI
The Remedē EL X sleep apnea therapy. [Image from Zoll]Zoll Medical announced that it received FDA approval for its Remedē system for conditional use with magnetic resonance imaging (MRI).
Read more
Chelmsford, Massachusetts-based Zoll designed its Remedē system as an implantable, transvenous phrenic nerve stimulation therapy. It treats adults with moderate to severe central sleep apnea (CSA). Full-body MRI approval applies to all models of the system and covers new patients as well as existing ones.
Dr. Asim Roy, medical director of the Ohio Sleep Medicine Institute, said in a news release that CSA patients often suffer from other co-morbidities. These comorbidities may benefit from MRI scanning, including brain, spine and joint issues.
Remedē initially received FDA approval in 2017. The implantable device activates automatically each night to simulate the phrenic nerve in the chest. This sends signals to the diaphragm to help restore a more normal breathing pattern.…
Stratasys and Desktop Metal plan $1.8B merger
Stratasys (Nasdaq:SSYS) and Desktop Metal (NYSE:DM) plan to combine in a $1.8 billion all-stock transaction, the 3D printing companies said today.
The companies estimate they will generate $1.1 billion in 2025 revenue after the merger and said they expect the additive manufacturing industry to grow to $100 billion by 2032. Stratasys and Desktop Metal both serve medical device developers and the broader healthcare industry.
“The transaction unites the polymer strengths of Stratasys with the complementary industrial mass production leadership of Desktop Metal’s brands, creating an additive manufacturing company that is expected to be well-positioned to serve the evolving needs of customers in manufacturing,” the companies said in a news release.
Stratasys CEO Yoav Zeif will remain chief executive of the company, while Desktop Metal co-founder, CEO and Chair Ric Fulop will serve as the combined company’s board chair.
Stratasys Chai…
Boston Scientific won’t buy majority stake in M.I. Tech
Boston Scientific (NYSE:BSX) will no longer be acquiring a majority stake in Korea-based medical device manufacturer M.I. Tech.
The Marlborough, Massachusetts-based company announced plans to acquire a 64% stake in M.I. Tech in June 2022. It valued the deal at approximately $230 million.
At the time, the company expected to close the transaction by the end of 2022. However, the deal remained contingent on certain conditions, including regulatory approvals. Those required approvals contributed to the termination of the agreement.
Boston Scientific will instead acquire a nearly 10% stake in M.I. Tech, according to a company spokesperson. M.I. Tech’s offerings include the Hanarostent family of conformable, non-vascular, self-expanding metal stents, which Boston Scientific has distributed the platform in Japan since 2015.
Stat News reported the change of plans on May 24. The Boston Scientific spokesperson provided the following statement on the …
Convatec, Beta Bionics partner on iLet bionic pancreas
The iLet Bionic Pancreas with a Dexcom G6 CGM and Convatec infusion set. [Image courtesy of Convatec/Beta Bionics]Convatec announced that it partnered with Beta Bionics on the launch of the iLet Bionic Pancreas for automated insulin delivery.
Read more
FDA last week cleared the Beta Bionics iLet ACE automated insulin pump and iLet dosing decision software.
Convatec offers design and manufacturing services for infusion set technologies and insertion devices for insulin pump treatment. Beta Bionics’ iLet uses its inset and contact detach infusion sets for subcutaneous insulin administration.
The company’s inset, an all-in-one infusion set with a built-in insertion device, connects to iLet on one end and the infusion site at the other. It features a soft, indwelling cannula. Convatec’s contact detach comes with a thin, stainless steel needle. Both infusion sets use kink-free infusion tubing to ensure uninterrupted insulin infusion. They also feature a …
Insilico Medicine wins IND approval for AI-designed USP1 inhibitor for cancer trials in U.S. and China
Insilico Medicine has made a significant breakthrough with its AI-designed USP1 inhibitor, ISM3091. The US Food and Drug Administration (FDA) has accepted Insilico’s Investigational New Drug (IND) application for this promising drug, marking a significant milestone for AI-assisted drug discovery.
“The FDA’s acceptance of our IND for ISM3091 signifies that the FDA recognizes its potential value, and we can now open clinical trial sites across multiple centers and begin to study ISM3091 in human patients who may benefit from novel therapies,” said Dr. Sujata Rao, senior vice president, head of global clinical development at Insilico Medicine.
The company’s discovery and development of drug candidates, including ISM3091 and ISM001-055, which has also progressed to the clinic, showcases the efficiency and cost-effectiveness of AI in accelerating drug development. ISM001-055, a potentially first-in-class small molecule inhibitor for idiopathi…
HeartBeam wins AI-related patent for handheld vector ECG
[Image courtesy of HeartBeam]HeartBeam (Nasaq:BEAT) announced today that it received a key patent relating to AI capabilities for its AIMIGo system.
Read more
The U.S. Patent and Trademark Office (USPTO) issued the allowance for a patent titled “Hand Held Device for Automatic Cardiac Risk and Diagnostic Assessment.” The patent describes a system that combines recorded cardiac signals from AIMIGo with the patient’s symptoms and cardiac risk factors. Together, this calculates a cardiac risk score to provide simplified diagnostic information and actionable instructions.
Santa Clara, California-based HeartBeam said this aims to replicate the decision-making process of a physician assessing cardiac symptoms. However, with AIMIGo, it occurs remotely and in an automated manner.
HeartBeam developed AIMIGo as a personal, portable vector electrocardiogram (VECG) system. It assists patients and clinicians in assessing cardiac symptoms. It utilizes a reusable, credit card-…
Medtronic to acquire wearable insulin patch maker EOFlow for $738M
[Image from the EOFlow website]Medtronic (NYSE:MDT) announced today that it entered into a set of agreements to acquire insulin delivery technology developer EOFlow.
Read more
Seongnam, South Korea-based EOFlow develops the EOPatch, a tubless, wearable and fully disposable insulin delivery device.
EOFlow already launched its EOPatch insulin delivery system in Korea and Europe. The company submitted the insulin delivery device for U.S. FDA clearance in January. EOFlow already has FDA breakthrough device designation on a wearable, integrated artificial pancreas. The disposable device features a glucose monitoring sensor, insulin pump and automated insulin delivery algorithm.
Medtronic plans to add EOFlow’s offerings to its existing diabetes portfolio. That includes its Meal Detection Technology algorithm and next-generation continuous glucose monitor (CGM). The medtech giant just one month ago received FDA approval for its own insulin delivery technology, the Min…
What’s new in 3D printing: medical devices, research, innovation, automation and partnerships
This 3D-printed robotic heart can simulate how a specific cardiac patient will benefit from different valve implants.[Image courtesy of Melanie Gonick/MIT]
3D printing is helping more patients than ever before through personalized medical devices, faster and cheaper prototyping and more affordable manufacturing.Recent developments include research into tissue and organ regeneration, lightning-fast responses to supply chain shortages, wearables that improve patient treatment, and major investments by device manufacturers.
Here are some of the 3D printing advances that show what the future may hold.
Next>>
Fast Five: Boston Scientific adds 400 jobs in Ireland, ICU Medical recalls some infusion pump batteries
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, May 25, 2023.
Fast Five by MassDevice · Boston Scientific adds 400 jobs in Ireland, ICU Medical recalls some infusion pump batteriesArtivion has received FDA premarket application approval for its PerClot absorbable hemostatic system, designed to control bleeding in surgical procedures. The approval marks a significant milestone for Artivion, which will now transfer full ownership to Baxter following a sale agreement in July 2021. Fast Five hosts Sean Whooley and Danielle Kirsh give all the details of the transaction and what technology is involved in PerClot.
Stryker has announced that surgeons have initiated early product surveillance cases for its Q Guidance system with cranial guidance software. The system, designed as an image-based planning and intraoperative platfo…
Medtronic says its annual revenue could grow up to 4.5%
Medtronic (NYSE: MDT) + today reported fourth-quarter results that beat the consensus forecast on Wall Street amid accelerating revenue growth.
The world’s largest medical device company also announced an acquisition: roughly $738 million for South Korea–based EOFlow and its EOFlow insulin delivery patch that a user can control using their smartphone.
Medtronic forecast that it will grow revenue up to 4.5% in the new fiscal year — a turnaround from the 1.4% revenue decline it saw in its fiscal year 2022–23. However, its earnings forecast for the new fiscal year appeared to come up a bit short of The Street’s expectations.
The initial earnings release and presentation included no additional details about the layoffs taking place amid significant cost reductions as the company seeks to refocus and drive growth.
Investors appeared to be initially positive about the results. MDT shares were up sli…
The economics behind the Adderall shortage: Why low prices lead to scarcity
[Image courtesy of Adobe Stock]
On October 12, 2022, the FDA confirmed what many patients with attention-deficit / hyperactivity disorder (ADHD) already knew: There was a shortage of the immediate-release formulation of amphetamine mixed salts commonly known by the brand name Adderall. The implications of this announcement have rippled across the United States, affecting scores of patients reliant on the medication. More than six million adolescents in the U.S. have been diagnosed with ADHD, according to the CDC. In addition, another eight million adults, or roughly 5% of Americans, have the condition. A dramatic drop in prescriptionsAccording to data from Definitive Healthcare, Adderall prescriptions fell 24% in January 2023, marking the largest month-over-month drop in more than two years.
Definitive Healthcare derives this data from their ClaimsMx product, which collects and updates information mon…