Congress passes continuing resolution reauthorizing FDA user fees; bill heads to Biden for signature

President Biden is expected to sign last-minute deal to fund the government, that includes a “clean” bill without amendments to fund FDA review activities for five years.

By Elise Reuter • Updated Sept. 30, 2022

Bionic pancreas led to lower blood sugar levels than standard of care: study

The results point to the potential for a simplified approach for automated insulin delivery that could be particularly useful for patients without regular access to an endocrinologist.

By Elise Reuter • Sept. 29, 2022

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Medical device safety in spotlight after high profile recalls

From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.

By MedTech Dive staff

Cyber risks identified in Canon Medical product used to view medical images, security firm says

Vulnerabilities in Canon Medical’s Vitrea View product could provide access to patient information and other services, according to cybersecurity firm Trustwave Spiderlab.

By Ricky Zipp • Updated Sept. 30, 2022

B. Braun acquires suite of catheter securement products from Starboard medical for undisclosed amount

The six acquired devices would improve patient care and extend B. Braun’s position in IV therapy, the company says.

By Elise Reuter • Sept. 28, 2022

FDA makes case for ‘new regulatory paradigm’ amid hurdles in software-oversight program

The agency seeks to tailor requirements based on the latest science, the benefits and risks posed by devices, their real-world performance and their contribution to promoting health equity.

By Nick Paul Taylor • Sept. 27, 2022

Hospital procedures have remained steady since H2 in boost for medtechs, survey finds

Evercore ISI analysts said the findings bode well for device companies, even as hospitals expect capital spending to drop next year.

By Elise Reuter • Sept. 26, 2022

Philips’ latest BiPAP machine recall labeled Class I event by FDA

Certain bi-level positive airway pressure devices feature plastic that could cause machines to stop working suddenly, potentially leading to serious injury or death, the FDA said Friday.

By Nick Paul Taylor • Sept. 26, 2022

Pros and cons of custom devices for HealthTech use cases

To meet the needs of both your specific use case and strict regulations, should you go custom?

Sept. 26, 2022

Device makers with ethylene oxide facilities at risk of lawsuits after Sterigenics loss: Needham

The $363 million award in the Sterigenics lawsuit “could lead to increased aggressiveness on the part of attorneys,” Needham analysts warned in a Friday note to investors.

By Ricky Zipp • Sept. 23, 2022

Forget oximeters, smartphone cameras detect 79% of cases of low blood oxygen in small study

If the results are validated by wider studies, physicians will have a new tool to increase the number of people who can be monitored for chronic and acute respiratory conditions. 

By Nick Paul Taylor • Sept. 23, 2022

Medtronic gets first FDA approval for drug-eluting stent in bifurcation lesions

Researchers have found the one-device, provisional stenting method delivers better results than two stents in some patients.

By Nick Paul Taylor • Sept. 22, 2022

Diabeloop’s insulin algorithm shows 17-point rise in time-in-range from year-long patient study

About half of the people using its device achieve the recommended outcomes, versus 27% of those using standard treatment.

By Nick Paul Taylor • Sept. 22, 2022

Insulet’s Omnipod 5 gains CE Mark for European release

After months of regulatory delays, Insulet’s newest insulin pump can now be marketed in the U.S. and European Union.

By Nick Paul Taylor • Sept. 21, 2022

Abbott’s FreeStyle Libre linked to 67% drop in hospitalizations for Type 2 diabetes patients: study

After switching to the continuous glucose monitor, patients had fewer acute diabetes-related events such as severe hypoglycemia and diabetic ketoacidosis.

By Nick Paul Taylor • Sept. 21, 2022

Medtronic issues urgent notice about MiniMed insulin pump system vulnerability

Unauthorized users could hack into the device while it’s being set up, and cause the pump to deliver too much or too little insulin, potentially resulting in outcomes including death.

By Nick Paul Taylor • Sept. 21, 2022

J&J opens new research hub near San Francisco

The roughly 200,000-square-foot facility will house about 400 employees and more than double the size of the drugmaker’s presence in San Francisco.

By Delilah Alvarado • Sept. 20, 2022

Zimmer Biomet gets FDA clearance for Identity shoulder system

Ivan Tornos, the company’s chief operating officer, said in August that it would be Zimmer’s biggest shoulder launch in five years.

By Elise Reuter • Sept. 20, 2022

Jury decides against Sterigenics in ethylene oxide trial, awarding $363M to the sole plaintiff

Sterigenics has more than 760 lawsuits pending against it in the local court for toxic emissions previously emitted by the plant.

By Nick Paul Taylor • Sept. 20, 2022

Hurricane Fiona unlikely to significantly disrupt medical device supply: analysts

Medtech management teams expect fewer problems than after Hurricane Maria in 2017, noting that Hurricane Fiona is less severe and companies are better prepared.

By Nick Paul Taylor • Sept. 20, 2022

Abbott’s latest Amulet-Watchman data show more mixed results for the heart devices

The latest head-to-head trial adds to the growing rivalry between Abbott and Boston Scientific in the left atrial appendage closure space.

By Ricky Zipp • Sept. 19, 2022

FDA updates advice about Medtronic endotracheal tubes after Class I recall, patient death reports

The FDA provided more detailed recommendations on preventing and responding to airway obstruction that may occur when using some Medtronic endotracheal tubes.

By Peter Green • Sept. 19, 2022

Medtronic starts full US commercial release of updated Evolut TAVR system

Medtronic expects the device’s new features to increase its share of the multibillion-dollar heart valve replacement market.

By Nick Paul Taylor • Sept. 19, 2022

Edwards gets FDA nod for mitral regurgitation treatment

The approval would bring a U.S. competitor to rival Abbott’s MitraClip device. 

By Elise Reuter • Sept. 16, 2022

Racial bias in pulse oximeters to be subject of FDA panel

The design of the ubiquitous fingertip monitors has inadvertently caused false blood oxygen readings in darker-skinned patients, a problem the FDA hopes to fix.

By Peter Green • Sept. 16, 2022

Edwards head of TAVR, Larry Wood, says more urgency needed in treating heart valve disease

Continued staffing shortages at hospitals are delaying the non-invasive aortic valve procedures for patients in need. 

By Elise Reuter • Sept. 16, 2022