Latest Listings

View More Listings

MedTech News

Know Labs to raise up to $12M for non-invasive CGM tech

A rendering of the KnowU non-invasive glucose monitor. [Image courtesy of Know Labs]Know Labs (NYSE:KNW) announced that it entered into a funding agreement for an investment worth up to $12 million.

The Seattle-based company executed a $4 million close as part of this investment with Lind Global Fund II. The Lind Partners, a New York-based institutional fund manager, manages Lind Global Fund II.

Funding helps Know Labs work toward bringing its non-invasive continuous glucose monitoring (CGM) technology to market. The company unveiled KnowU, its wearable CGM set for FDA submission, earlier this week. KnowU’s sensor uses spectroscopy to direct electromagnetic energy through a substance or material. Through this, it can capture a unique molecular signature. The technology integrates into wearable, mobile or bench-top form factors.

Get the full story at our sister site, Drug Delivery Business News.

Read more
  • 0

GLP-1s, ADCs, AI and the future of pharma

Pharma’s potential breakthroughs in AI, ADCs, and GLP-1 receptor agonists raise a critical question: can innovation outpace the relentless rise of chronic disease?

The IQVIA Institute for Human Data Science sheds light on this theme, among many others, in its 80-page Global Trends in R&D 2024 report.

Pillar 1: GLP-1 receptor agonists targeting metabolic disease

Speaking of next-gen metabolic therapies in particular, Murray Aitken, the executive director of the IQVIA Institute for Human Data Science, sees significant potential. Market projections for GLP-1 drugs are bullish, with some analysts projecting sales potentially hitting $100 billion by 2030. “It’s exciting because if the market for these drugs becomes as big as anticipated, it means they are truly being disruptive in a positive way to human health for hundreds of millions of people worldwide,” said Aitken

New metabolic therapies are sorely needed as the obesity epidem…

Read more
  • 0

Vivani prices $15M offering to support long-term drug delivery implant

NanoPortal technology. [Image courtesy of Vivani]Vivani Medical (Nasdaq:VANI) announced today that it entered into a securities purchase agreement worth $15 million in proceeds.

The company entered the agreement with an institutional investor. It covers the purchase of just shy of 4 million shares of common stock and warrants to purchase common stock. Alameda, California-based Vivani priced the shares at $3.80 apiece. Warrants have the same exercise price, immediate exercisability upon issuance and an expiration date of three years post-issuance date.

Vivani did not list an intended use of proceeds, but funds could go toward the continued development of its drug delivery implant technology.

Get the full story at our sister site, Drug Delivery Business News.

Read more
  • 0

Medtronic wins FDA clearance for bone tumor ablation tech

Medtronic (NYSE: MDT) + announced today that it received FDA 510(k) clearance for its OsteoCool 2.0 bone tumor ablation system.

The medtech giant designed OsteoCool 2.0 to treat painful bone metastases and benign bone tumors like osteoid osteoma. The minimally invasive procedure uses probes to deliver radiofrequency energy that heats and destroys tumors. Meanwhile, it circulates water to cool the probes in close proximity to the active tip to avoid excess heating.

With an upgraded design, the OsteoCool radiofrequency ablation system offers a number of new advantages over the previous generation. Medtronic’s system enables the simultaneous use of four internally-cooled probes. This allows physicians to ablate two vertebral bodies at once, or create larger ablation zones in extra-spinal applications.

According to a news release, it’s the most powerful bone tumor ablation system on the market, deliverin…

Read more
  • 0

iRhythm teams up with Epic to streamline Zio access

The next-generation Zio patch. [Image courtesy of iRhythm Technologies]iRhythm (Nasdaq: IRTC) + announced that it plans to use Epic’s Aura platform to streamline access to its Zio long-term monitoring and telemetry services.

With this collaboration, iRhythm can make Zio more readily available to healthcare providers using Epic. That also applies to the more than 250 million patients in the U.S. who have a health record in Epic.

The company said in a news release that it plans to partner with early adopter customers to integrate Zio into Aura in the fourth quarter of 2024. It expects to begin offering the solution to existing and new Zio customers beginning in early 2025.

iRhythm designed the Zio long-term ambulatory cardiac monitor to detect potential cardiac arrhythmias. Zeus, the company’s advanced, deep-learned AI algorithm, supports the capture and analysis of ECG data recorded by Zio. The company secured…

Read more
  • 0

Philips, SyntheticMR partner on AI-based brain imaging

The Smart Quant Neuro 3D brain imaging platform. [Image courtesy of Philips/SyntheticMR]Philips (NYSE: PHG) + announced today that it launched its Smart Quant Neuro 3D for brain disorder diagnosis and therapy.

The company unveiled the system at ECR2024 in partnership with Swedish MRI software solutions company SyntheticMR. Smart Quant Neuro 3D provides objective decision support for disorders like multiple sclerosis (MS), traumatic brain injury (TBI), and dementia.

According to a news release, the technology provides auto-measurement of various brain tissues. This enhances decision support of rain disease and helps assess progression and monitor the effect of therapy. Its analysis of myelin volumes also provides objective assessments for traumatic brain injuries. Previously, these were only diagnosed through symptom-based tests, Philips says.

The platform combines Philips’ AI-based SmartSmeed image-reconstruc…

Read more
  • 0

FDA reportedly finds animal lab issues at Neuralink facility

A screen grab from a Neuralink video of a monkey playing Pong through its BCI. [Image courtesy of Neuralink]Reuters reports that FDA inspectors identified issues with record keeping and quality controls for animal experience at Neuralink.

This isn’t the first time questions have been raised over the Elon Musk-backed brain-computer interface company’s animal practices. Over the past couple of years, the company has drawn concerns over animal welfare and hazardous material transport practices.

Reuters‘ report comes amid the company’s first-in-human trial for its brain implant, a trial approved by the FDA in May. Just last week, Musk said that the first patient to receive the Neuralink implant fully recovered and can control a computer mouse using their thoughts. Musk claimed that “progress is good and the patient seems to have made a full recovery with no ill effects that we are aware of.”

According to the report, the FDA flagged the i…

Read more
  • 0

FDA clears new radiotherapy systems from Siemens Healthineers’ Varian

The TrueBeam imaging system now has FDA clearance with HyperSight technology. [Image from Varian]Varian announced today that it received FDA 510(k) clearance for its TrueBeam and Edge radiotherapy systems with HyperSight imaging.

The Siemens Healthineers company designed HyperSight to empower clinicians to accurately tailor treatments to individual patients. This helps improve patient outcomes, thanks to new capabilities and workflows across the company’s linear accelerators.

HyperSight allows clinicians to acquire high-quality images during a patient’s daily course of radiation treatments. It helps to improve the ability to target tumor volumes more precisely and spare healthy tissue for patients undergoing radiation therapy.

Adding HyperSight to the Varian line of linear accelerators means the company’s portfolio can produce images that deliver the Hounsfield Unit (HU) accuracy necessary for treatment planning directly on the acquired co…

Read more
  • 0

FDA approves Boston Scientific’s Agent drug-coated balloon

The Agent drug-coated balloon. [Image from Boston Scientific]Boston Scientific  (NYSE: BSX) + announced today that it received FDA approval for its Agent drug-coated balloon (DCB).

The DCB won approval for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. ISR occurs when plaque or scar tissue obstructs or narrows a stented vessel.

Marlborough, Massachusetts-based Boston Scientific plans a U.S. launch for Agent in the coming months. It already has availability in Europe, parts of Asia Pacific and Latin America. The system treats patients with ISR and previously untreated small vessel coronary disease.

Agent serves as an alternative to traditional therapies like balloon angioplasty, additional layers of stenting or radiation. The paclitaxel-coated balloon transfers a therapeutic dose of drug to the vessel wall, helping to prevent ISR reoccurrence.

The FDA approved the device,…

Read more
  • 0

Fast Five: Medtronic asks ITC to stop Axonics’ neuromod device sales; J&J’s Varipulse PFA wins CE mark approval

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, March 1, 2024.

Fast Five by MassDevice · Medtronic asks ITC to stop Axonics’ neuromod device sales; J&J’s Varipulse PFA wins CE mark approval

Orthofix this week appointed a new president of its Bone Growth Therapies business. Fast Five hosts Danielle Kirsh and Sean Whooley discuss who is joining the company and some of their career experience.

Affluent Medical has positive biomimetic mitral valve data. Learn more about the valve and some of the data points that study out.

Onward won an FDA breakthrough nod for use of neurostim with brain-computer interface. Whooley explains what the technology does and how this was a milestone breakthrough for the company.

J&J’s Biosense Webster’s pulsed field ablation system won CE mark approv…

Read more
  • 0

This novel catheter system could yield safer transseptal procedures

The UltraNav Transseptal Catheter System houses transeptal needles and wires with the intracardiac echocardiography catheter, optimizing safety and efficacy of transseptal procedures

By Nabil Dib, Dib UltraNav Medical

The Dib UltraNav Transseptal Catheter System [Photo courtsy of Dib UltraNav Medical]

Cardiologists conducted approximately 375,000 transseptal left heart procedures for closures, valvuloplasty, repairs, septostomies, and electrophysiology in 2021. It is estimated that around 900,000 transseptal heart procedures will be performed in 2025.

The significant rise in procedure volume presents both challenges and opportunities.

The challenges include a correlated rise in procedural complications. Even though the percentage of procedures with complications is overall very low — 1-2% of procedures involving transesophageal echo (TEE), for example, result in unintended perforations — the rapid…

Read more
  • 0

Dri-Air launches MD (MicroDryer) Series

NEWS RELEASE: Dri-Air Introduces the MD (MicroDryer) Series On Display at NPE 2024 – Booth W909

Dri-Air said its MicroDryer compressed air dryers are designed for very low throughputs, with hopper capacity ranging from 1 to 15 lbs. [Photo courtesy of Dri-Air]

East Windsor, CT, February 29, 2024 – Dri-Air Industries, Inc is pleased to introduce a new product series in their extensive dryer line for the plastics industry.  Known throughout the industry for their desiccant dryers, Dri-Air is now manufacturing a micro line of compressed air dryers with matching hoppers.

The MicroDryer Series (MD) is a line of sleek, compressed air dryers designed for very low throughputs.  The series of dryers start with the MD-1 equipped with drying hoppers with a capacity of 1-3 lbs and range up to the MD-3 with the largest capacity of 15 lbs. Low dewpoints, -40F and below, are assured as the dryer is equipped with a membrane and…

Read more
  • 0

From gatekeeper to strategist: The evolution of the CISO role in drug development

[Gorodenkoff/Adobe Stock]

There’s an old joke about chief information security officers (CISOs) being gatekeepers of new technologies and initiatives – the infamous “Department of No.” Imagine a bouncer who, strangely, doesn’t let anyone in, saying the club is already too full, even when it’s clearly empty.

But that image is outdated — especially in risk-focused industries like financial services where CISOs are integral to digital transformation projects and the broader risk management considerations. 

From CIS-‘no’ to risk maestro

“Drug development is a risk-focused industry as well,” said Daniel Ayala, chief security and trust officer for Dotmatics. “There is a huge amount of risk.” Consequently, CISOs working in pharma contexts are increasingly expanding their roles from technical experts to risk-aware business leaders who happen to have deep technical expert…

Read more
  • 0

FDA submission for 365-day CGM from Senseonics is ‘imminent’

The Eversense E3 system. [Image from Ascensia/Senseonics]Senseonics (NYSE:SENS) shares dipped after hours on fourth-quarter results that came in ahead of the consensus forecast.

The company also reported an “imminent” submission of its latest, longest-lasting continuous glucose monitoring (CGM) technology.

Shares of SENS fell 3.5% to 69¢ apiece after the market closed today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — closed the day down 0.6%.

Get the full story at our sister site, Drug Delivery Business News.

Read more
  • 0

Bristol Myers Squibb plans $400M expansion in Ireland

A rendering of the new Cruiserath campus in Dublin, Ireland. [Image courtesy of Bristol Myers Squibb]

Bristol Myers Squibb announced that it invested $400 million to build a sterile drug product (SDP) facility in Dublin, Ireland.

This Cruiserath facility will support the manufacturing and supply of existing medicines and serve as a launch excellence facility for pipeline assets. It marks the first European SDP facility for biologics manufacturing at Bristol Myers Squibb. It remains in the design phase, according to a news release.

Bristol Myers Squibb plans to begin construction in March 2024. With planning approval granted, it expects to complete construction in 2026.

The company anticipates a further 350 positions created in Ireland as a result of the investment. That brings the total for the company in Ireland to 1,000 at that campus. The new investment and the roles it creates significantly exp…

Read more
  • 0

Philips unveils new AI-enabled CT imaging tech

The CT 5300 system. [Image courtesy of Philips]Philips (NYSE: PHG) + announced today that it launched its CT 5300 system, a flexible X-ray CT platform with advanced AI capabilities.

Amsterdam-based Philips says the system increases diagnostic confidence, streamlines workflow efficiency and maximizes system up-time. It helps to improve overall patient outcomes and department productivity. Philips unveiled the new system at ECR2024.

CT 5300 meets advanced diagnostic imaging requirements for cardiac care patient guidelines, according to Philips. The company says it also offers utility in other challenging areas like trauma care and interventional procedures. Additionally, the system features virtual tools for real-time collaboration and clinical/technical support.

Philips also designed the system for more accessibility and lower energy consumption.

With Nanopanel Precise, the company’s first detector buil…

Read more
  • 0

Zeus sale to private equity firm EQT closes

Zeus is officially under new ownership after private equity firm EQT closed on its acquisition of the medical tubing supplier.

“Today marks the start of a new chapter for our company, and we’re excited to share this update with you,” Zeus said in an email to “industry partners” announcing the deal’s finalization. “We believe this partnership will allow us to continue to grow and create innovative products to help our customers be successful. We remain focused on our people, our customers, and our partners.”

With the transaction’s closing, former Hillrom CEO John Groetelaars is now Zeus’ executive chair.

EQT and Zeus have not released the purchase price or other terms of the deal. Bloomberg reported in December that the deal valued Zeus at $3.4 billion, citing unidentified “people with knowledge of the matter.”

Earlier this week, EQT said their EQT X target fund hit a hard ca…

Read more
  • 0

Orthofix announces new president of Bone Growth Therapies

Jason Shallenberger, Orthofix’s new president of Bone Growth Therapies [Image courtesy of Orthofix]Orthofix Medical (NASDAQ:OFIX) is promoting from within to fill a new business president position at the company.

The Lewisville, Texax–base spine and ortho tech company announced today that it moving its Bone Growth Therapies business out from under the leadership of its Spine business.

Jason Shallenberger, previously the VP of U.S. sales and marketing for the Bone Growth Therapies business, is now Orthofix’s president of Bone Growth Therapies.

“Jason has led sales and marketing for this successful franchise for a number of years,” Orthofix President and CEO Massimo Calafiore said in a news release. “Under his guidance, the sales team has produced quarter-after-quarter of double-digit growth in 2023. I am confident he will do an amazing job as President and continue to contribute greatly to the success of Orthofix.”

Shallenberger said he wa…

Read more
  • 0

Affluent Medical has positive biomimetic mitral valve data

The Epygon mitral valve. [Image from Affluent Medical]Affluent Medical today announced positive findings in a clinical evaluation of its Epygon device for replacing mitral valves.

The Aix-en-Provence, France-based company designed Epygon to replace mitral valves in those with mitral insufficiency. Epygon is the first biomimetic transcatheter mitral valve to mimic the native mitral valve and restore the natural vortex of blood flow in the left ventricle, according to a news release. The transcatheter implant process enables a fast, minimally invasive procedure that helps avoid open-heart surgery.

Epygon is the first biomimetic transcatheter mitral valve to mimic the native mitral valve and restore the natural vortex of blood flow in the left ventricle. Its transcatheter implantation makes it a fast and minimally invasive procedure, avoiding open heart surgery.

Transcatheter mitral valve replacement (TMVR) is growing in popularity. Both Medtronic (Intrepid) a…

Read more
  • 0

Covestro publishes climate neutrality targets for scope 3 emissions

NEWS RELEASE: Covestro publishes climate neutrality targets for scope 3 emissions Reduction of 10 million metric tons of greenhouse gases produced in upstream and downstream supply chains (scope 3) by 2035, climate neutrality for scope 3 by 2050 Climate strategy for reducing greenhouse gases complete  Concrete plan for implementation to reduce emissions, transformation along the entire supply chain required

PITTSBURGH, February 29, 2024 — Covestro has published its climate neutrality targets for scope 3 emissions, completing its climate strategy for reducing greenhouse gas emissions. As a short-term goal, the company plans to reduce greenhouse gases by 10 million metric tons by 2035. This corresponds to a drop in emissions of 30 percent compared to the base year 2021, with some growth-related emissions through 2035 included in the calculation. In the long-term, Covestro plans to be climate-neutral in terms of scope 3 emissions by 2050.

Covestro previously publ…

Read more
  • 0

ClearPoint Neuro prices $15M offering

ClearPoint Neuro (Nasdaq:CLPT) announced today that it priced an underwritten public offering worth approximately $15 million.

The company is offering 2,307,694 shares of its common stock at a price to the public of $6.50 per share. It also granted the underwriter a 30-day option to purchase up to an additional 346,154 shares of common stock at that offering price. ClearPoint Neuro is offering all shares in this case.

According to a news release, the company expects the offering to close on March 4, 2024, subject to customary closing conditions.

Solana Beach, California-based ClearPoint Neuro plans to use proceeds from the offering for general corporate purposes. That may include R&D, potential acquisitions or investments or repayment of debt. Lake Street Capital Markets serves as the sole book-running manager for the proposed offering.

This marks the latest boost for ClearPoint Neuro, which kicked off 2024 with a series of milestones. In Janu…

Read more
  • 0