FDA takes N95 respirators off medical device shortage list

Respirators were one of the first medical devices identified as being in critical shortage during the COVID-19 public health emergency, the agency said.

By Ricky Zipp • Aug. 29, 2022

Akili CEO Martucci sees ‘massive’ need for company’s ADHD video-game treatment

With enough cash now to last two years, the company hopes it can change the way children with ADHD are treated, offering an alternative to pharmaceuticals.

By Elise Reuter • Aug. 29, 2022

Explore the Trendline➔

Top 5 stories from MedTech Dive

From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

Medtronic reports six more injuries, one additional death related to HVAD battery problems

The company pulled the heart pump from the market last year, after the FDA received word of more than 3,000 deaths linked to various problems with the device, according to published reports.

By Elise Reuter • Aug. 26, 2022

Penumbra’s catheters achieve first-pass revascularization in 68.9% of stroke patients

A separate study found the device cleared clots in patients with tandem lesions, meeting the criteria for successful restoration of blood flow in 84% of subjects.

By Nick Paul Taylor • Aug. 26, 2022

Review finds ‘paucity of robust evidence’ on impact of AI clinical outcomes

Of the nearly 12,000 articles on artificial intelligence, only 39 described randomized controlled trials, making it difficult to quantify the clinical benefits of using AI-assisted tools for patient care.

By Nick Paul Taylor • Aug. 26, 2022

Medtronic gets CE mark for drug-eluting stent and kicks off European launch

Medtronic calculated that changes to the stent resulted in a 16% improvement in drug deliverability.

By Nick Paul Taylor • Aug. 25, 2022

Integra pulls intracranial pressure monitors for inaccurate readings

After announcing an immediate voluntary removal of the devices, Integra trimmed its sales forecast for the quarter.

By Elise Reuter • Aug. 24, 2022

Abbott wins FDA approval for spinal cord stimulation treatment of multi-site pain

The approval gives Abbott a new angle as it seeks to win market share from Boston Scientific, Medtronic and Nevro.

By Nick Paul Taylor • Aug. 24, 2022

Getinge’s recall of 11,000 ventilators labeled Class I event by FDA

The company is fixing a software bug that can inadvertently stop the ventilator from working.

By Nick Paul Taylor • Aug. 24, 2022

Philips respirator lawsuit builds as plaintiffs’ attorneys outline lengthy recall delays

New filings in a class action lawsuit allege that Philips waited years to disclose the risk of foam used in its sleep apnea machines and respirators, causing illness and injuries.

By Elise Reuter , Peter Green • Updated Aug. 23, 2022

Medtronic CEO says supply chain starting to stabilize as sales dropped, profits rose in Q1

The company is keeping its revenue forecast for fiscal year 2023 as it works to resolve issues with packaging and resins. 

By Elise Reuter • Aug. 23, 2022

Insulet’s Omnipod 5 insulin delivery system approved for preschool children

Adding preschoolers will broaden the market for the Omnipod after the launch of the device for people aged six years and older helped Insulet boost U.S. sales by 31% in the second quarter.

By Nick Paul Taylor • Aug. 23, 2022

Teleflex will buy Standard Bariatrics for $170M to gain Titan stapler

Standard’s investors could receive an additional $130 million if the unit reaches certain commercial milestones under Teleflex’s ownership.

By Elise Reuter • Aug. 22, 2022

Laser vision correction procedures fell 16% in the second quarter

The slowdown raises questions about whether demand is waning or if there was a pull-through in procedures last year.

By Elise Reuter • Aug. 22, 2022

Medical device industry poised to withstand an economic slowdown, experts say

While procedures volumes may decline, analysts said the effects likely won’t reach levels seen in 2020 or during the Great Recession.

By Ricky Zipp • Aug. 22, 2022

Edwards gets CE mark for Pascal Precision system, allowing device to be marketed in Europe

The system, which is used to treat patients with mitral or tricuspid regurgitation, is also expected to get FDA approval by the end of the year.

By Elise Reuter • Aug. 19, 2022

Friday Q&A: ResMed CEO Mick Farrell discusses Philips recall, improving supply chain, prioritizing patients

The executive spoke about managing a 12-month patient backlog following a spike in demand due to Philips’ recall and supply constraints.

By Ricky Zipp • Aug. 19, 2022

Medtronic gets third Class I label in 2022 for latest HVAD recall

The latest recall is for nearly 40,000 batteries for the HeartWare Ventricular Assist Device system.

By Ricky Zipp • Aug. 19, 2022

Eargo plans to sell its hearing aids in stores after over-the-counter ruling

Best Buy, which announced it would sell over-the-counter hearing aids in more than 300 stores, has listed the Eargo 6 as one of the products it will offer.

By Elise Reuter • Aug. 18, 2022

Medical device recalls hit two-year high in Q2, report finds

While the number of recalls jumped in the period, the total units affected dropped to the lowest point in five years.

By Ricky Zipp • Aug. 18, 2022

New entrants may shake up hearing-aid market after FDA clears path for OTC sales

Startups, large tech companies and even traditional hearing-aid manufacturers are expected to offer over-the-counter devices. 

By Elise Reuter • Aug. 17, 2022

Moderna, after firing newly hired CFO, finds replacement in PerkinElmer executive

The COVID-19 vaccine maker has appointed James Mock, currently PerkinElmer’s CFO, as its next finance head, three months after ousting Jorge Gomez from the role. 

By Ned Pagliarulo • Aug. 17, 2022

Philips’ next CEO, Roy Jakobs, provides ‘continuity’ amid ongoing recall: Barclays

Roy Jakobs currently leads the company’s connected care business and has helped oversee its recall response.

By Ricky Zipp • Aug. 17, 2022

Visibly wins FDA clearance for self-administered online vision test

The agency has placed restrictions on the test, limiting it to adults aged 22 to 40 years and cautioning that it only gives “supportive recommendations.”

By Nick Paul Taylor • Aug. 17, 2022

FDA reviews rise in Philips respiratory device reports, including 44 deaths

The agency received more than twice as many reports linked to foam breakdown from May to July than from April 2021 to April 2022.

By Nick Paul Taylor • Aug. 17, 2022