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

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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

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

Baxter’s recall of solution sets used in chemotherapy labeled Class I by FDA amid complaints of leaks

The regulator says the leaks could kill, but with 83 complaints it has not received reports of patient injuries or deaths.

By Ricky Zipp • Sept. 15, 2022

Tasso’s at-home blood collection lancet wins FDA clearance

Tasso is pitching the device as an enabler of decentralized clinical trials because it could simplify the collection of blood at home.

By Nick Paul Taylor • Sept. 15, 2022

FBI warns of cyber risks from legacy medical devices

Outdated device software can put data, patient safety and hospitals’ operations at risk, the top U.S. law enforcement agency warned.

By Ricky Zipp • Sept. 15, 2022

Medtech firms increasingly positive about future as staffing, inflation pressures ease, say RBC analysts

Hospital staffing and supply chain issues are expected to improve, according to comments from Boston Scientific, J&J, Medtronic, and others.

By Nick Paul Taylor • Sept. 15, 2022

Medtronic reports two deaths related to endotracheal tube recall

The company also received reports of three injuries related to airway obstruction with the tubes, adding to the company’s recent recall woes.

By Elise Reuter • Updated Sept. 14, 2022

Edwards updates Sapien TAVR device for greater durability

The device uses Edwards’ Resilia tissue technology to enable dry storage and potentially extend device durability.

By Nick Paul Taylor • Sept. 14, 2022