LivaNova receives FDA nod for heart-lung machine

After beginning its European rollout last month, the UK-based device maker hopes to bring its market-leading position to the U.S.

By Peter Green • March 10, 2023

Friday Q&A: A regulatory attorney breaks down the EU MDR transition

Amsterdam-based regulatory expert Erik Vollebregt explains the agreement this week to extend the deadlines to comply with the EU’s Medical Device Regulation, and the issues that still need to be addressed.

By Susan Kelly • March 10, 2023

Explore the Trendline➔

Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

Ex-medtech CEO arrested over alleged scheme to sell dummy devices, defraud Medicare

Prosecutors accuse the former Stimwave CEO of engaging in a multi-year scheme to sell a device with no medical purpose for implantation into chronic pain patients.

By Nick Paul Taylor • March 10, 2023

Titan delisted from Nasdaq, as surgical robot maker struggles to sell assets

Titan's robotic surgery device faced delays in development that forced the firm to put off a planned FDA submission. The company has laid off its technical staff as it seeks to sell its assets.

By Elise Reuter • March 9, 2023

J&J lays off 350 people at robotics units, says ‘we have to get better’ with Ottava

CFO Joe Wolk said there is “a sense of urgency” at the company as it works to come from behind in the robotic surgery market.

By Nick Paul Taylor • Updated March 10, 2023

More woes for breast implants, as FDA links procedure to squamous cell carcinoma

Three deaths were related to the cancer cases, the agency said.

By Elise Reuter • March 8, 2023

iRhythm, fighting Boston Scientific for market share, shows cardiac monitor beats rivals

An analysis of Medicare claims data found iRhythm Technologies’ Zio XT outperforms other ambulatory cardiac monitors.

By Nick Paul Taylor • March 8, 2023

Sooma’s neuromodulation therapy for depression granted FDA breakthrough status

The patient-administered device, which uses a mild electrical current to improve depressive symptoms, showed promising results in a clinical trial. 

By Nick Paul Taylor • March 8, 2023

Medtronic’s pulsed field ablation device meets safety, efficacy metrics in trial

Medtronic’s device didn’t outperform competing systems being developed by J&J and Boston Scientific, but the results should be enough to secure FDA approval, one analyst wrote.

By Elise Reuter • March 7, 2023

AdvaMed calls Europe’s MDR extension a ‘strong step forward,’ but warns challenges remain

The extra time to certify medical devices in Europe is intended to prevent shortages, but the regulatory overhaul still poses problems for medtech firms, the U.S. lobbying group says.

By Susan Kelly • March 7, 2023

Medtronic TAVR data in healthier patients fuels battle with Edwards for heart valve market share

The results show that low-risk aortic stenosis patients have better outcomes after three years when catheters are used to insert their replacement heart valves, rather than traditional open-heart surgery.

By Nick Paul Taylor • March 7, 2023

Medtechs plan to centralize regulatory information management in modernization push: survey

The survey suggests that more than two-thirds of medtech firms need to update and automate their regulatory record-keeping and submission practices.

By Nick Paul Taylor • March 7, 2023

Abbott CGMs cleared to integrate with automated insulin delivery systems

The regulatory decision allows the devices to be used in artificial pancreas systems, and positions Abbott as a competitor to Dexcom in the space. 

By Elise Reuter • March 6, 2023

Abbott’s TriClip improves tricuspid regurgitation in pivotal trial ahead of showdown with Edwards

The transcatheter repair clip beat the established medical therapy on the primary composite endpoint, setting up a battle with rival Edwards for a $5 billion market.

By Nick Paul Taylor • March 6, 2023

Elon Musk’s bid to study brain implant in humans rejected by FDA on safety grounds: report

The FDA reportedly raised concerns about the device’s lithium battery, the potential for its wires to migrate across the brain, and how it would be removed.

By Nick Paul Taylor • March 3, 2023

FDA Class I recalls hit 15-year high in 2022

The jump in activity happened in a year in which the number of all recalls rose by around 10%, including actions by Baxter, Medtronic and Philips.

By Nick Paul Taylor • March 3, 2023

Medtronic says renal denervation consensus could open up multibillion-dollar market

European recommendation will help to start talks with insurers, says Medtronic executive.

By Elise Reuter • March 2, 2023

AdvaMed unveils policy priorities with focus on breakthrough device coverage, global market access

Congress should also prioritize protecting the medtech manufacturing supply chain and enact diagnostic testing reform, the lobbying group said in releasing a set of nine policy goals.

By Susan Kelly • March 1, 2023

Boston Scientific to lay off 120 people at ex-Preventice site, continuing run of medtech cuts

The job cuts are related to Boston Scientific moving some of the Texas facility’s work to a site in Minnesota. 

By Nick Paul Taylor • March 1, 2023

ReCor follows Medtronic in making case for renal denervation as FDA mulls approval decision

An analysis of three clinical trials linked the intervention to consistent reductions in blood pressure.

By Nick Paul Taylor • March 1, 2023

Abbott heart valve deteriorates faster than rival device, FDA says in notice

The FDA is concerned that the rate of early deterioration may be higher for Trifecta than for other surgical aortic valve replacements such as Edwards’ Magna device.

By Nick Paul Taylor • Feb. 28, 2023

GE HealthCare forms Chinese joint venture to sell non-premium imaging systems

The new firm will make medical equipment with a focus on primary care and rural health, putting it in competition with local manufacturers in China. 

By Nick Paul Taylor • Feb. 28, 2023

Olympus agrees to $370M gastrointestinal stent takeover as medtech M&A rebound continues

The deal for Korea-based Taewoong, which makes stents used to help clear blockages, supports Olympus’ plan to expand in the GI market.

By Nick Paul Taylor • Feb. 28, 2023

European cardiologists recommend renal denervation as an adjunctive blood pressure treatment

The recommendation could open markets in Europe for the blood-pressure reduction therapy for patients who have already tried lifestyle changes and medications to treat high blood pressure.

By Elise Reuter • Feb. 27, 2023

Medtronic links MiniMed 780G automated insulin delivery to sustained glucose control benefits

The data indicates patients should receive automated insulin delivery earlier, rather than starting treatment with multiple daily injections, Medtronic said.

By Nick Paul Taylor • Feb. 27, 2023