Medical Devices: Page 76
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Medtronic's Martha says supply chain woes may ease in second half
The CEO told a conference he’s working on plans to revamp pricing as inflation rises and developing a strategy for advancing robotic surgery.
By Nick Paul Taylor • June 16, 2022 -
Stefan Zaklin via Getty Images
User fee package goes to Senate with lab-developed test, OTC hearing aid provisions
The Senate HELP committee passed its version of the FDA user fee bill by a 13-9 vote. It includes an overhaul of diagnostic testing regulations and a requirement to create a category of over-the-counter hearing aids.
By Elise Reuter • June 15, 2022 -
Explore the Trendline➔
Sitthiphong via Getty Images
TrendlineMedical 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 -
ResMed to acquire German health software company MediFox for $1B
The acquisition continues a pattern of medical device companies buying software platforms. ResMed expects the deal to close by the end of the year.
By Ricky Zipp • June 14, 2022 -
Permission granted by Apple
Apple Watch monitoring features for AFib, Parkinson's cleared by FDA
With the new feature, atrial fibrillation patients may have an easier way to track the frequency of the condition over time and see whether lifestyle changes may have positive effects.
By Nick Paul Taylor • June 14, 2022 -
Sarah Silbiger via Getty Images
Dräger's breathing system filter recall gets Class I label from FDA after ventilation obstruction
An obstruction in one of the company’s SafeStar 55 devices resulted in a patient being resuscitated after becoming hypoxic.
By Nick Paul Taylor • June 13, 2022 -
Spencer Platt via Getty Images
Medical device companies to curb spending as recession threat clouds longer-term outlook: analysts
The supply chain and inflation issues that have affected medical device companies in the first half of 2022 likely will persist through the rest of the year, according to RBC Capital Markets.
By Nick Paul Taylor • June 13, 2022 -
Андрей Клеменков via Getty Images
ResMed warns supply constraints may last 18 months after Philips completes recall of sleep-apnea devices
Analysts at William Blair expect ResMed to achieve “durable market share gains, bordering on permanent” because of Philips’ recall, which affects millions of sleep-apnea and ventilator devices.
By Nick Paul Taylor • June 10, 2022 -
UnitedHealth links CGM use in people with Type 2 diabetes to improved blood sugar control
J.P. Morgan analysts said they see the results as evidence that continuous glucose monitors have a role to play in support packages for people with Type 2 diabetes.
By Nick Paul Taylor • June 10, 2022 -
Win McNamee/Staff via Getty Images
House passes FDA user-fee package, bolstering cybersecurity, clinical trial diversity for medical devices
By a 392-28 vote, the House of Representatives passed its version of the legislation, which would renew the Food and Drug Administration's ability to collect user fees for the next five years.
By Elise Reuter • June 9, 2022 -
Medtronic: No new patient injury, death reports since April letters warning of HVAD defect
The company’s HeartWare Ventricular Assist Device System received a Class I label from the FDA following two patient injuries and one death.
By Ricky Zipp • Updated June 14, 2022 -
Insulet Omnipod 5 release
Insulet targets competitive conversions as Omnipod 5 insulin pump nears full launch
The company said at a conference it aims to increase the rate of insulin pump use among people with Type 1 diabetes in the U.S.
By Nick Paul Taylor • June 9, 2022 -
Sarah Silbiger via Getty Images
GE Healthcare ventilator battery recall tied to over 1,500 complaints
Ventilators risk shutting down prematurely — cutting the flow of oxygen to patients — as backup batteries may run out of power earlier than expected.
By Nick Paul Taylor • Updated June 28, 2022 -
Sarah Silbiger via Getty Images
FDA mulls pilot program on alternative sterilization for medical devices
The proposed initiative is a response to global supply chain constraints and is intended to support sterilization supply chain resiliency, the agency said.
By Nick Paul Taylor • June 8, 2022 -
Permission granted by Becton Dickinson
BD to acquire Parata for $1.53B as part of strategy to boost margins
The deal is expected to help Becton Dickinson reach its goal of a 25% operating margin by the end of 2025. J.P. Morgan analysts said it would be the most meaningful tuck-in deal since BD acquired Bard in 2017.
By Elise Reuter • June 7, 2022 -
Permission granted by Dexcom
Q&ADexcom CEO Sayer on G7 FDA submission, developing a 15-day sensor, M&A plans
Kevin Sayer spoke about the company's back-and-forth with the FDA on the G7 CGM system, possibly expanding from a 10-day to a 15-day sensor and on a report that Dexcom was in talks to buy Insulet.
By Ricky Zipp • June 7, 2022 -
Permission granted by Pear Therapeutics
Pear sets out payer strategy as it seeks to quadruple prescriptions of digital therapeutics
Pear shared real-world data that linked its digital therapeutic for substance use disorder to an estimated $3,591 reduction in per-patient costs.
By Nick Paul Taylor • June 7, 2022 -
Courtesy of Abbott
Abbott, Medtronic make case for key diabetes products in ADA presentations
Researchers at Abbott Laboratories used the event to highlight data on the FreeStyle Libre 3 continuous glucose monitor, while Medtronic arrived at the sessions with real-world results on the MiniMed 780G insulin pump.
By Nick Paul Taylor • June 6, 2022 -
Sarah Silbiger via Getty Images
Getinge's recall of 69,000 stents labeled as Class I event by FDA amid complaints, injuries
The recall relates to the separation of the balloon or catheter hub during the removal of the delivery system from the patient.
By Nick Paul Taylor • June 3, 2022 -
Medtronic expects diabetes unit's struggles to continue as rivals grow sales, launch products
The company forecasts revenues for the diabetes business to decrease 8% to 10% in the first quarter of its fiscal year and 6% to 7% for the full year.
By Ricky Zipp • June 1, 2022 -
Photo illustration by Danielle Ternes/MedTech Dive; photograph by spainter_vfx via Getty Images
BD's Pyxis medication dispenser gets fifth DHS cybersecurity alert in 5 years
The company said there are no known public exploits that specifically target a password vulnerability and that it's working to address the problem.
By Nick Paul Taylor • June 1, 2022 -
Sarah Silbiger via Getty Images
Recalled devices surged in first quarter, driven by BD connectors
A recall of 288 million Becton Dickinson connectors for catheter ports drove up the total number of recalled devices in the quarter. Mislabeling was the top reason for FDA alerts over the three-month period, a Sedgwick report found.
By Nick Paul Taylor • June 1, 2022 -
Courtesy of Boston Scientific
Boston Scientific would be 'good fit' for increasingly acquisitive J&J, analysts say
A limited portfolio overlap could make Boston Scientific a target should Johnson & Johnson's CEO seek a large medtech acquisition.
By Nick Paul Taylor • May 31, 2022 -
Courtesy of Abbott
Abbott's Libre 3 glucose monitor gets FDA clearance as CGM market intensifies
The 14-day glucose sensor is smaller and thinner than its predecessor, and will give Abbott a head start on rival Dexcom’s newest continuous glucose monitor.
By Nick Paul Taylor • May 31, 2022 -
Courtesy of Abbott
Abbott's imaging catheter recall gets Class I label from FDA over vascular injury risks
The proximal markers in the Dragonfly OpStar Imaging Catheters can become loose and separate from the device while in use.
By Nick Paul Taylor • May 27, 2022 -
Medtronic expects supply chain issues to continue after 'catastrophic explosion' last quarter
The company expects revenue to be down 4.5% to 5.5% next quarter, assuming no near-term improvement in the supply chain.
By Elise Reuter • Updated May 27, 2022
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