Medtronic, 6 months after proposing patient monitoring spinoff, remains mum on separation plan

A standalone entity could achieve faster growth, even though recent spinoffs in the medtech sector have produced mixed results, analysts say.

By Susan Kelly • April 14, 2023

Fewer Philips replacement devices have reached patients than counted, FDA says

The agency raised concerns that the discrepancy could affect the estimated wait times for patients needing a replacement sleep apnea device.

By Elise Reuter • April 14, 2023

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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

Medtronic targets June closure of Epix facility, will lay off 59 employees

The company had bought Epix for a catheter-based, temperature-controlled cardiac ablation system designed to treat patients with irregular heartbeats.

By Nick Paul Taylor • April 14, 2023

Digital surgery firm Surgalign faces delisting by Nasdaq for shareholder equity noncompliance

The exchange has given Surgalign 45 days to submit a plan to regain compliance.

By Nick Paul Taylor • April 14, 2023

OTC hearing aid matches performance of audiologist-fitted device in small trial

People who used an over-the-counter hearing aid for six weeks saw similar results to people who used an audiologist-fitted device, suggesting less costly, self-fitted hearing aids could be an option. 

By Nick Paul Taylor • April 13, 2023

Medtech sector poised for growth as healthcare staffing tops pre-COVID levels: KeyBanc

The analysts are “leaning into increased medtech exposure” after determining that several challenges that have constrained the industry are easing.

By Nick Paul Taylor • April 13, 2023

Zimmer’s ‘smart knee’ implant may qualify for new technology payments from CMS

If finalized, the add-on payments would help cover the cost of the sensor technology included in the company’s Persona IQ knee implants.

By Elise Reuter • April 12, 2023

FDA starts device sterilization pilot program to help industry adapt to EtO emission clampdown

The FDA “recognizes the need to facilitate more timely changes” amid a push to cut EtO emissions and constraints on the supply of radioactive cobalt.

By Nick Paul Taylor • April 12, 2023

Medical device groups say ‘the stakes are high’ with new EtO regulations

AdvaMed, which represents medical device companies, warned that patients could face treatment delays if sterilization facilities close.

By Elise Reuter • April 11, 2023

EPA to limit ethylene oxide emissions from medical device sterilizers

The agency proposed new emissions limits that device sterilization companies would have 18 months to meet.

By Elise Reuter • April 11, 2023

GE HealthCare faces ‘competition from all angles’ that could constrain growth: analysts

BTIG lists 20 companies as competitors to GE HealthCare, including China’s Shenzhen Mindray Bio-Medical Electronics and Shanghai United Imaging Healthcare.

By Nick Paul Taylor • April 11, 2023

Medtech buyouts by private equity in Q4 shed light on deal-making trends in 2023: report

Medtech companies are continuing to spin off assets to realign portfolios, creating opportunities for private equity firms to buy businesses and exit existing investments.

By Nick Paul Taylor • April 11, 2023

Philips recalls 1,200 reworked sleep apnea devices over fault that can cause therapy failure

The problems keep mounting for Philips, as recently repaired respirators now need to be fixed in a recall the FDA has labeled a Class I event.

By Nick Paul Taylor • April 10, 2023

EPA proposes stricter ethylene oxide pollutant rules for chemical makers

Further EPA proposals involving medical device sterilization plants are expected to be forthcoming.

By Susan Kelly • April 7, 2023

Friday Q&A: Fujifilm’s Henry Izawa on navigating a tough hospital equipment market

The CEO of Fujifilm Healthcare Americas discusses integrating Hitachi’s diagnostic imaging business, new product launches and how hospital budgets are changing the market for imaging.

By Elise Reuter • April 7, 2023

Sernova defends record after investors attack ‘sluggish’ progress of regenerative medicine implant

The investors accused Sernova’s board of “complacently” overseeing “a period of eroding shareholder value.”

By Nick Paul Taylor • April 7, 2023

Abbott faces Class I recall of 4.2M glucose readers on battery fire risks

Readers for Abbott’s FreeStyle Libre glucose monitoring systems could catch fire if improperly stored or charged, the FDA says.

By Peter Green • Updated April 7, 2023

Bioventus CEO departs after CartiHeal acquisition unravels

Ken Reali was asked to leave after a deal to buy CartiHeal fell apart. Bioventus’ share price has fallen more than 90% in the past two years. 

By Susan Kelly • April 6, 2023

Medtech servicing timelines and costs improve as technician turnover creates skills challenge

With experienced technicians retiring faster than their replacements are getting up to speed, the sector faces a potentially costly skills challenge.

By Nick Paul Taylor • April 6, 2023

Medtronic’s Hugo too similar to Intuitive’s surgical robot to displace the market incumbent: analysts

The analysts expect Medtronic to “find a place in specific markets” that Intuitive is yet to dominate.

By Nick Paul Taylor • April 5, 2023

Philips Trilogy Evo ventilators face another Class I recall

More trouble for Philips’ Respironics business as the company flags a problem with ventilators that could lead to under-delivery of oxygen due to inaccurate readings.

By Elise Reuter • April 4, 2023

Masimo receives De Novo nod from FDA for device designed to detect signs of opioid overdose

The system detects patterns associated with opioid-induced respiratory depression and sends alerts that escalate in line with the risk level.

By Nick Paul Taylor • April 4, 2023

Bain acquires Olympus life sciences unit for $3.1B

The company aims to expand its position as a workflow solution provider in life science and industrial markets.

By Susan Kelly • April 3, 2023

Medtronic, DaVita launch kidney care joint venture

The new company, called Mozarc Medical, will focus on kidney care technology including home dialysis.

By Elise Reuter • April 3, 2023

Grassroots innovation: How a patient-driven device for diabetes won FDA clearance

Tidepool Loop, an automated insulin dosing app based on one developed by the DIY diabetes community, received FDA clearance in January. 

By Elise Reuter • April 3, 2023