Medical Devices
-
Permission granted by Canary Medical
Q&AFriday Q&A: Canary Medical CEO Bill Hunter discusses knee-implant sensors, device reimbursement
Canary’s founder discusses how the firm plans to create predictive tools from data collected by the devices, and long-term plans to embed its sensors in other implants.
By Elise Reuter • July 1, 2022 -
Retrieved from LiveMetric website on July 01, 2022
LiveMetric's blood-pressure 'smartwatch' device gets FDA clearance
The wristwatch-like device will be made available though health systems, insurers and self-insured employers to ease continuous monitoring of blood pressure and avoid white-coat syndrome.
By Nick Paul Taylor • July 1, 2022 -
Trendline
The EU Medical Device Regulation
While the European Union’s MDR went into effect in May 2021, device makers still face a range of uncertainties and potential problems one year later.
By MedTech Dive staff -
Retrieved from Siemsens Website on July 01, 2022
Intuitive secures FDA clearance for lung biopsy robot featuring Siemens' imaging tech
The FDA clearance is an “incremental positive” for Intuitive, wrote analysts at RBC Capital Markets, adding that they see Ion as “an important leg of growth for the company.”
By Nick Paul Taylor • July 1, 2022 -
Courtesy of Philips
As Philips works to replace or repair recalled devices, supply problems are slowing it down
Logistical challenges mean patients won’t know when they will get a replacement sleep apnea or ventilator device until “at best a few weeks before it is delivered,” Philips executives said.
By Ricky Zipp • June 30, 2022 -
Courtesy of Cleveland Clinic
GE Healthcare powers Cleveland Clinic imaging spinout to $33M financing round
Centerline will use the funding to expand into Europe and other international markets next year, as well as to advance the use of its technology in new surgical applications.
By Nick Paul Taylor • June 30, 2022 -
SARINYAPINNGAM via Getty Images
Eargo reaches financing deal as it looks to regain insurance coverage after DOJ settlement
A $125 million financing deal puts pressure on the hearing aid maker to make a quick turnaround as it works to win back its largest customer, the Federal Employee Health Benefits Program.
By Elise Reuter • June 29, 2022 -
Permission granted by Zimmer Biomet
Deep DiveCompanies see a future for smart implants. Doctors are waiting for proof.
Zimmer Biomet and Canary Medical are rolling out the first knee implant with an integrated sensor, though it will take time to learn how to incorporate that data into patient care, experts say.
By Elise Reuter • June 28, 2022 -
N/A via Getty Images
Sleep apnea devices show 'very low' amount of degraded foam, Philips says
Philips found evidence of foam breaking down in about 2% of 60,847 returned first generation DreamStation devices. The company said the problem was more prevalent in devices that used an ozone cleaning method.
By Ricky Zipp • June 28, 2022 -
Permission granted by Becton Dickinson
BD recalls emergency vascular access devices over risk of delayed care
Because patients who need intraosseous access are often critically ill, Becton Dickinson warned delays to care caused by the device problems could lead to death.
By Nick Paul Taylor • June 27, 2022 -
Maks_Lab via Getty Images
Medtech M&A falls 85% but activity could rebound in second half: report
PwC highlights a range of barriers that could stop acquisitions, including supply chain issues, scrutiny from the Federal Trade Commission and geopolitical concerns.
By Nick Paul Taylor • June 24, 2022 -
Sarah Silbiger via Getty Images
Baxter ventilator recall labeled Class I event by FDA after 2 deaths
Baxter initiated the recall after learning that an improper setup could reduce oxygen flow to in-home users, causing serious injury or death.
By Nick Paul Taylor • June 24, 2022 -
Patient death prompts another recall of Medtronic's HVAD System
The company initiated another recall for the troubled heart pump after a patient died when two batteries simultaneously stopped working, the company said, adding to a list of safety problems with the device.
By Ricky Zipp • June 23, 2022 -
atiatiati via Getty Images
Bioventus agrees to staggered payment plan to close stalled $315M CartiHeal takeover
Rising interest rates quashed a plan for Bioventus to fund the takeover of the joint repair company with a bond offering. Now, the deal will get much more expensive, J.P. Morgan analysts said.
By Nick Paul Taylor • June 23, 2022 -
Sarah Silbiger via Getty Images
FDA opens consultation on tissue removal devices to reduce cancer risk
The agency is seeking feedback on draft guidance to help manufacturers of tissue containment systems reduce risk that cancerous tissue could leak during procedures.
By Nick Paul Taylor • June 22, 2022 -
Nastasic via Getty Images
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.
By Nick Paul Taylor • June 22, 2022 -
Pravinrus Khumpangtip via Getty Images
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.
By Nick Paul Taylor • June 21, 2022 -
Carl Court via Getty Images
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.
By Nick Paul Taylor • June 17, 2022 -
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.
By Nick Paul Taylor • June 16, 2022 -
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 -
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
