The Latest
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Lack of clinical evidence 'major gap' in digital health: study
The researchers framed the low scores as evidence of “a major gap in health care technology,” adding that there is a “significant opportunity” for companies that differentiate themselves with a more rigorous approach.
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Deep Dive
As cross-state telemedicine waivers expire, virtual care advocates focus on long-term policy changes
There’s a complication: No one solution to the U.S.’ patchy physician licensing infrastructure has universal buy-in.
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ZimVie faces challenges in focus on slow-growing, 'highly competitive' spine market: JP Morgan
Still, as a standalone company, the Zimmer spinoff may benefit from tapping higher-growth sub-segments, according to analysts.
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How a sports apparel company helped one Virginia health system pivot to reusable gowns
Personal protective equipment shortages forced Inova to find new ways to protect workers.
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Medical device user fee update inches closer to approval
After the FDA was delayed in getting a draft to Congress, the House and the Senate are working to pass legislation that would reauthorize the fifth Medical Device User Fee Amendments.
Updated June 21, 2022 -
GE Healthcare says contrast media production back to full capacity
The shortage of the injectable used for medical imaging started in April, when the company’s plant in Shanghai shut down due to rising COVID-19 cases.
Updated June 17, 2022 -
Senseonics lands CE mark for 6-month CGM implant, teeing up Q3 launch in Europe
Senseonics is looking to the longer-lasting implant to re-energize its fight in a market dominated by Abbott Laboratories and Dexcom.
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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.
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Boston Scientific inks $230M deal to buy majority stake in M.I.Tech
M.I.Tech is a South Korean manufacturer of endoscopic and urologic medical devices. Analysts at BTIG said the deal complements Boston Scientific’s non-vascular stent portfolio and boosts its international presence.
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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.
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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.
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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.
Updated June 14, 2022 -
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.
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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.
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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.
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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.
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Oracle closes $28B buy of 'huge growth engine' Cerner
With the deal’s close, the days of standalone EHR vendors are increasingly in the rearview mirror.
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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.
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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.
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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.
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GE Healthcare's recall of ventilator batteries gets Class I label from FDA over device shutdown risk
Ventilators risk shutting down prematurely — cutting the flow of oxygen to patients — as backup batteries may run out of power earlier than expected.
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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.
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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.
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Q&A
Dexcom 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.
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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.