Medical Design and Outsourcing Archives - Page 83 of 154

FDA can’t explain record-low medical device recalls

Medical device product recalls were down 14.3% in the federal government’s fiscal year 2021, according to a recent Medical Design & Outsourcing analysis of recall data.

The drop was the biggest since the FDA began publicly reporting the data in 2013, and came as the regulating agency put more emphasis on fighting the COVID-19 pandemic.

We reached out to the agency for more information and connected with FDA press officer Jim McKinney, who said in an email that the FDA could not speculate on the significant reduction in device recalls and recall events, but that the numbers should not be viewed as an indicator of general safety.

The following has been lightly edited for space and clarity.

MDO: We found that medical device recalls were down 14.3% and device recall events were down 18.1% in fiscal 2021. Why was the recall rate down? Was it driven by COVID-19?

McKinney: The number of devices recalled in a year is not an indicator of t…

The promise and pain of startup customers: 3 ways to support early-stage innovators without becoming a high-risk investor

Kate Stephenson is the owner and founder of Dyad Engineering. [Photo courtesy of Dyad Engineering]

Startups represent a highly lucrative opportunity for suppliers to get in on the ground floor of a whole new product line, but their low success rate and high-touch needs can make them a dangerous distraction from your main customers.

Kate Stephenson, Dyad Engineering

Enthusiastic and highly committed to their cause, medical device startup founders speak with a deep passion about righting the wrongs of healthcare and the immense potential for profit in doing so.

However, they also tend to be overly confident, naïve about the sheer amount of work their idea represents and perennially underfunded.

The risks and rewards of working with startups are constantly shifting. To mitigate the risks without resorting to a blanket “no startup” policy, there are three strategies every medical device manufactur…

Portescap is returning to MD&M West

It’s the first time Portescap has exhibited at MD&M West since early 2020. [Image courtesy of Portescap]

Portescap will use next week’s MD&M West in Anaheim, California to show off its wide variety of miniature medical monitors.

It’s the first time Portescap has exhibited at MD&M West since early 2020.

The company will demo its Surgical Motor Solutions, including sterilizable motors and controllers designed to withstand more than 3,000 autoclave cycles. It will also showcase recent innovations including the CNT1530 sterilizable motor controller for surgical hand tools and new additions to its line of Ultra EC brushless DC motors.

With electronics and software encapsulated in a single enclosure, the CNT1530 provides simplified system integration, according to Portescap. It’s compatible with typical NiMH and LiOn battery voltages, features 20 amps of continuous cu…

Emerson introduces new three-way miniature solenoid valve

The new ASCO Series 090 three-way miniature solenoid valve [Image courtesy of Emerson]

Emerson (NYSE:EMR) announced the expansion of its ASCO Series 090 line of miniature solenoid valves.

The product line includes a new three-way Series 090 valve configuration. The three-way configuration enables lighter, more space-efficient solutions for gas control in oxygen therapy, compression therapy and gas analyzer devices, St. Louis–based Emerson said in a news release posted yesterday.

Originally developed as a two-way valve for air and inert gases in portable medical devices, the Series 090 valve features a compact architecture, small (10.8 mm footprint and 50-million-cycle life.

Because the Series 090 valve’s new three-way configuration can perform the same mixing and diverting functions as a pair of two-way valves, it provides more design flexibility for high-precision gas delivery systems for o…

Integer buys Aran Biomedical for $131.1 million

Integer (NYSE:ITGR) announced today that it acquired Connemara Biomedical and its subsidiaries Aran Biomedical and Proxy Biomedical (collectively “Aran”).

Aran offers development and manufacturing solutions for implantable medical devices, including proprietary medical textiles, high-precision biomaterial coverings and coatings along with advanced metal and polymer braiding.

The deal to acquire Aran Biomedical is worth $131.1 million (€120 million) with up to an additional $10.9 million (€10 million) in contingent consideration based on 2022 revenue growth milestones.

Plano, Texas-based Integer said in a news release that Galway, Ireland-based Aran further increases its ability to offer complete solutions for complex delivery and therapeutic devices in high-growth cardiovascular markets, including structural heart, neurovascular, peripheral vascular and endovascular, as well as in general surgery.

Integer said Aran’s Ireland head…

FDA clears antibiotic-embedded hernia mesh for fighting implant infections

Ariste Medical’s polypropylene hernia mesh [Image courtesy of Ariste Medical]

Ariste Medical recently won FDA 510(k) clearance for its drug-embedded, polypropylene hernia mesh to fight microbial colonization.

The Salt Lake City-based drug-device developer said the patents and proprietary formulations behind the technology could prevent infection, inflammation or clotting associated with implants.

Ariste’s synthetic mesh carries two antibiotics — minocycline and rifampin — to prevent contamination by MRSA, E. coli and other bacterial pathogens associated with surgical site infections. The proprietary formulation can be applied to a variety of medical devices and incorporate any drug to address infection, restenosis, thrombosis and inflammation, the company said.

Ariste Medical co-founder and Chief Scientific Officer Lisa Jennings […

Johnson & Johnson faces another ballot battle on racial equity audit

Johnson & Johnson is fighting another shareholder proposal for an independent racial equality audit of the company.

New Brunswick, New Jersey–based J&J (NYSE:JNJ) defeated a similar measure at last year’s annual meeting of shareholders, though the vote was far from a landslide. The company also unsuccessfully petitioned the U.S. Securities and Exchange Commission to keep it off the ballot.

Now, an independent audit is again up for consideration at the April 28 annual meeting after surviving another J&J appeal to the SEC.

Proponents of the audit cite ongoing controversies over talcum powder allegedly marketed to minorities. They also point to the J&J Political Action Committee’s financial support of Republican members of Congress who voted to overturn President Joe Biden’s election after insurrectionists stormed the U.S. Capitol.

“Perhaps not since the civil rights era of the 1960s have citizens spoken with a…

How Embecta is ‘uniquely positioned’ in diabetes space following spinoff from BD

Unlike most “new” companies, Embecta enters the playing field with nearly a century of history in diabetes.

Nearly one year after BD (NYSE:BDX) announced its intent to spinoff its diabetes business, Embecta (Nasdaq:EMBC) now stands on its own.

On April 1, the spinoff was made official, and Embecta became a standalone, publicly-traded company aiming to make waves in the diabetes industry. However, unlike most companies just entering the space, Embecta comes in with a wealth of experience, according to former Worldwide President of BD Diabetes Care and new Embecta CEO Devdatt Kurdikar, who spoke with Drug Delivery Business News following the spinoff’s completion on April 1.

“Our mission is to develop and provide solutions for people with diabetes, Kurdikar said. “While we might be a newly listed company today, we have a 98-year history of being in this business. Insulin itself has been used to treat diabetes since 1922, and just two years after that, we i…

Endosmart partners with Chamfr to provide nitinol components for medical devices

Endosmart today announced it partnered with Chamfr to provide nitinol components for medical devices online.

Through the partnership, engineers can order selected nitinol braids, shape-set tubes and wires and grinder wires from Chamfr’s website.

Get the full story on our sister site, Medical Tubing + Extrusion.

New M1 MedTech accelerator opens applications for first cohort

M1 MedTech Director of Programs Sean Bittner [Photo courtesy of M1 MedTech]

The new M1 MedTech accelerator is now taking applications from early-stage medical device developers for its first fall cohort.

The program — sponsored by contract research organization Proxima Clinical Research, based in Houston’s Texas Medical Center — said it has closed its first fund and wants “five to seven of the most promising early-stage medical device companies” for the three-month program.

M1 MedTech will select companies this summer for investments of up to $100,000 in the form of cash and in-kind services. The program’s coaching includes “a curated educational program, interactive workshops where participants can continually build out specific company deliverables, and tailored one-on-one mentoring,” M1 MedTech said in a news release.

“Our program is unique in that it combine…

Medtronic releases new renal denervation results, closes trial enrollment

The Symplicity Spyral renal denervation system delivers energy to the nerves leading to the kidneys, which help regulate blood pressure. [Image courtesy of Medtronic]

Medtronic (NYSE:MDT) today said its Symplicity Spyral renal denervation (RDN) system demonstrated durable, clinically significant blood pressure reductions through three years for patients on medication.

It’s the latest development out of Medtronic’s Spyral HTN-ON MED trial testing the company’s RDN catheter system, which delivers radiofrequency energy to overactive nerves near the kidneys that cause high blood pressure. Medtronic released the results in The Lancet and at the American College of Cardiology’s 71st Annual Scientific Session.

“For the first time, we now have randomized data that demonstrates that in a typical patient population — hypertension patients who are on anti-hypertensive medications and t…

Junkosha honors Creo Medical CTO as the winner of its its Technology Innovator of the Year Awards

Junkosha announced today that it is awarding Creo Medical founder and CTO Chris Hancock with a $25,000 prize as the winner of its inaugural Technology Innovator of the Year Awards.

The U.K.-based company has created an advanced energy multimodality instrument developed for flexible endoscopy. According to Junkosha, Creo Medical’s technology combines the benefits of bipolar RF and super high-frequency microwave energy to provide the ability to dissect, resect, coagulate and inject in a single device — producing results that could reduce cancer recurrence.

“Chris’ breakthrough technology holds the potential to transform the point of treatments for a range of cancers. Overall, Chris’ achievement is one we can use as a yardstick to measure others in future years,” said Joe Rowan, Junkosha’s president and CEO in the U.S. and Europe.

Said Junkosha CEO Mamoru Sogo: “We believe that enabling innovators, like Creo Medical, is central to th…