Judge rules in favor of Illumina-Grail merger, countering FTC concerns

A ruling by a federal administrative judge makes it more likely Illumina can keep control of its one time subsidiary, which makes cancer tests. A European Union anti-competition review is still pending. 

By Ricky Zipp , Elise Reuter • Updated Sept. 2, 2022

Medtronic grows patient monitoring offerings with BioIntelliSense partnership

Wearable patient monitors can help with healthcare staffing shortages, an ongoing challenge for hospitals, and create an opportunity for device makers.

By Ricky Zipp • Sept. 1, 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

Baxter gets 510(k) clearance for syringe pump, spurring optimism of faster FDA review process

Syringe pumps are a potential new driver of growth for Baxter, and analysts at J.P. Morgan called the clearance “a nice win for the company,” as FDA timelines for pumps more broadly have remained “a challenge” for medtech companies. 

By Nick Paul Taylor • Sept. 1, 2022

Malfunctioning Integra intracranial monitor was used on patient who died: FDA

The team caring for the patient had to replace the sensor in a malfunctioning monitor, but Integra determined that the death was unrelated to the device, the agency said. 

By Nick Paul Taylor • Sept. 1, 2022

Invacare drops CEO, changes board amid broader restructuring

With seven of its eight directors independent of management under an accord with its largest investor, the company is working to rebound from supply chain problems.

By Elise Reuter • Aug. 31, 2022

Jury orders BD unit to pay $4.8M to patient in latest hernia mesh case

The award comes amid a string of defeats for major medical device makers over alleged injuries from surgical mesh products.

By Ricky Zipp • Aug. 31, 2022

Philips settles government claim for $4.2M over military certification of portable patient monitors

Philips conceded that it had failed to recertify the MP2 patient monitor for safe use in airplanes after modifying the devices it was supplying to the U.S. Army and Air Force.

By Elise Reuter • Aug. 31, 2022

Recall Watch: Hamilton ventilator, Intera pump recalls get Class I label from FDA

The FDA assigned the recalls to its most serious risk category in light of the potential for serious injuries and deaths.

By Nick Paul Taylor • Aug. 30, 2022

Olympus to sell microscope unit for $3.1B as it bolsters focus on medical technology

Bain Capital has taken the other side of the deal, paying $3.1 billion for a business it said is “at the frontier of digital optical technology in life sciences and industrial end markets.”

By Nick Paul Taylor • Aug. 30, 2022

Abbott HeartMate 3 LVAD shows improved survival rate compared to older heart pump

After five years, Abbott found that patients implanted with the HeartMate 3 LVAD had an improved survival rate compared to those implanted with the HeartMate II. 

By Elise Reuter • Aug. 29, 2022

Philips recalls some BiPAP machines because of contaminated plastic

The FDA said the latest action is not associated with the company’s sleep apnea machine recall, although some devices are affected by both.

By Ricky Zipp • Aug. 29, 2022

Medtronic’s extravascular ICD meets safety, efficacy endpoints in recent study

The data could give Medtronic a competitor to Boston Scientific’s subcutaneous implantable defibrillator system.

By Elise Reuter • Aug. 29, 2022

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

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