‘Business as usual?’ Investors weigh in on future of medtech startup financing after SVB collapse

Some VC firms say the impact may be limited, while others expect fundraising challenges to linger.

By Elise Reuter • March 20, 2023

Olympus accused of ‘troubling disregard for patient safety’ by FDA after flurry of warning letters

The agency’s investigation included a complaint that cracked endoscope caps caused a patient to suffer esophageal trauma.

By Nick Paul Taylor • March 20, 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

FDA sets end date for raft of COVID-related shortages that began early in pandemic

Shortages of home-use ventilators and clinical sample concentrators are expected to continue.

By Nick Paul Taylor • March 20, 2023

Trade group warns FDA human factors proposal is ‘too expansive,’ will strain agency resources

Other groups gave a warmer welcome to the plan, with AdvaMed suggesting specific edits without criticizing the overall approach.

By Nick Paul Taylor • March 17, 2023

Medtech trade group pushes UK to support ambitious Software as a Medical Device program

Reams of data collected by the National Health Service, paired with advanced work in artificial intelligence at U.K. universities, could make Britain a digital health leader if the government acts. 

By Nick Paul Taylor • March 15, 2023

Illumina shares jump 17% after Icahn launches proxy fight

The activist investor said his board nominees would work to prevent Illumina from “sinking further into the quicksand” in a battle with regulators over the Grail acquisition.

By Susan Kelly • Updated March 14, 2023

Baxter issues urgent correction for ventilation system due to risk of oxygen desaturation

Patients can continue to use the devices if they are checked daily and properly maintained, the company said in an announcement posted by FDA.

By Susan Kelly • March 13, 2023

Medtech groups lose challenge to digital piracy rule in device repair case

Repair companies will still be able to access and use operating code to fix medical devices, after the court rejected arguments by AdvaMed and the Medical Imaging & Technology Alliance.

By Susan Kelly • March 13, 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

QuidelOrtho COVID test is first to win FDA nod via premarket review

Special controls instituted by the FDA as part of the De Novo assessment pave the way for other tests to come to market without pandemic-era Emergency Use Authorization.

By Nick Paul Taylor • March 9, 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

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

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

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

Medtech industry relieved as Europe’s MDR extension nears final approval

While the extra time to comply is aimed at preventing medical device shortages, the rules have still left some device makers and certifying bodies unclear about how to proceed, says one attorney.

By Susan Kelly • 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

Medicare to expand CGM coverage to more Type 2 diabetes patients

The updated policy could double the market for continuous glucose monitors, and will take effect in April.

By Elise Reuter • Updated March 2, 2023

FDA moving ahead with rulemaking on lab developed tests without waiting for Congress: BioWorld

A senior FDA official said the agency cannot “just stand by” given the failure of Congress to pass legislation addressing regulation of the increasingly complex tests.

By Nick Paul Taylor • March 2, 2023

Remote patient monitoring increasingly popular, even as pandemic eases, analysis of insurance claims shows

Cardiologists are the main users of RPM devices, with blood pressure diagnoses accounting for more than half of all claims made in 2021. Diabetes, which accounts for 16% of claims, is the next most active area.

By Nick Paul Taylor • 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

FDA authorizes first at-home flu-COVID-19 combination test days after its developer files for bankruptcy

Lucira filed for bankruptcy protection last week, saying the “protracted” authorization process caused it to miss out on test sales in the 2022 to 2023 flu season.

By Nick Paul Taylor • Feb. 27, 2023

Getinge has CE marks suspended on life support sets over sterile packaging issues

Getinge said it is “aware of the severe situation this suspension puts on healthcare and critically ill patients” and is “working urgently to minimize the impact.”

By Nick Paul Taylor • Feb. 24, 2023

Biden upholds finding that Apple Watch violated AliveCor’s patents

A ban on the infringing Apple Watches could be enacted under a ruling by the International Trade Commission, but a separate patent case must be resolved first.

By Elise Reuter • Feb. 21, 2023

Device makers gain more time to adapt to Europe’s MDR after EU vote

The European Parliament’s approval means that medtech manufacturers have until 2027 or 2028 to comply with the new rules, depending on device class.

By Susan Kelly • Feb. 17, 2023