Medical Devices: Page 103
-
Google calls Fitbit acquisition complete despite ongoing DOJ review
The search giant closed the deal because the department's 14-month investigation period expired without any objection. However, DOJ could still sue to unwind the buy.
By Rebecca Pifer • Jan. 14, 2021 -
Intuitive, J&J, Medtronic and Zimmer talk robotic surgery ambitions: JPM21
Medtech majors used this week's virtual J.P. Morgan healthcare conference to talk up their plans in the hot, increasingly competitive sector.
By Nick Paul Taylor • Jan. 14, 2021 -
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 -
Brian Tucker/MedTech Dive
Remote monitoring, wearable companies look to capitalize on virtual care boom: JPM21
Diabetes players Dexcom and Insulet both projected business growth and market expansion for this year during presentations.
By Ricky Zipp • Jan. 14, 2021 -
Boston Scientific Q4 misses Wall Street, a laggard in early medtech previews: JPM21
The fourth quarter miss points to "further softness" in the first quarter as COVID-19 cases surge, J.P. Morgan analysts said.
By Greg Slabodkin • Jan. 13, 2021 -
UpperEdge
FDA issues action plan for regulating AI in medical devices
The proposal brings the agency a step closer to draft guidance for regulating the fast-evolving field of artificial intelligence and machine learning-based software in medical devices.
By Susan Kelly • Jan. 13, 2021 -
Steris inks $4.6B buy of Cantel Medical amid flurry of M&A
It's the biggest deal so far this year. Wall Street analysts said COVID-19 infection concerns should boost Cantel in the long term.
By Ricky Zipp • Jan. 13, 2021 -
CMS breakthrough rule called tailwind for Abbott, J&J and Medtronic
The policy gives developers of FDA-designated breakthrough products coverage for Medicare's 60 million beneficiaries on the day of approval.
By Nick Paul Taylor • Jan. 13, 2021 -
3 takeaways from JP Morgan: Electives, M&A and looking past COVID-19
Execs from Medtronic, Baxter and BD are among those previewing the year ahead at the bank's annual healthcare conference.
By Greg Slabodkin , Ricky Zipp • Jan. 12, 2021 -
In medtech win, MDR-IVDR remote audits OK'd amid pandemic pressures
An official for MedTech Europe, which pushed for flexibility ahead of new medical device rules set to kick in later this year, called the move "significant and positive."
By Nick Paul Taylor • Jan. 12, 2021 -
"State Capitol Building, USA, California, Sacramento" [Photograph]. Retrieved from Pixy.
California proposes expanding Medicaid coverage of continuous glucose monitors
The budget proposal seeks to increase access to CGMs among adults with Type 1 diabetes covered by the state's Medicaid program Medi-Cal. Abbott, Dexcom, Medtronic and Senseonics compete for the U.S. CGM market.
By Nick Paul Taylor • Jan. 11, 2021 -
Fotolia
Medtech M&A to take off after pandemic slowed deals in 2020: EY
Dealmaking in 2021 will be fueled by financial firepower across the industry at an "all-time high" of nearly $500 billion, according to the consultants.
By Ricky Zipp • Jan. 10, 2021 -
New Mexico sues device sterilizer Sterigenics over ethylene oxide emissions
The suit alleges ethylene oxide levels were often elevated due to "lax oversight" practices such as leaving sterilization chamber doors ajar.
By Nick Paul Taylor • Updated Jan. 7, 2021 -
Getty Images
Wall Street paints rosy 2021 for medtech as electives snap back
After economic challenges throughout 2020, sell-side analysts predict procedure-dependent companies like Medtronic, Abbott and Zimmer Biomet to outperform this year as procedure volumes return.
By Ricky Zipp • Jan. 7, 2021 -
French medtechs Carmat, CorWave advance heart failure device plans
Carmat is gearing up to start selling its artificial heart, while CorWave disclosed a $40 million financing round for its twist on the LVADs sold by companies including Abbott and Medtronic.
By Nick Paul Taylor • Jan. 7, 2021 -
Jacob Bell / BioPharma Dive
FDA finalizes speedier medical device pathway alternative to breakthrough status
Final guidance for the voluntary Safer Technologies Program features changes to draft sections criticized by AdvaMed, specifically what qualifies as a "significant" improvement to patient safety.
By Nick Paul Taylor • Jan. 6, 2021 -
Photo courtesy of Stryker
Stryker buys sensor maker in bet on wearables in orthopaedics
OrthoSensor's technology could complement the medtech's robotics platform and boost its data analytics capabilities, SVB Leerink analysts said in a Tuesday note on the acquisition.
By Susan Kelly • Jan. 5, 2021 -
Hologic eyes future post COVID-19 with Somatex Medical tuck-in
The medical device maker is bulking up its women's health business as molecular diagnostics sales surge due to the pandemic. Wall Street analysts have said these lines are equipped to withstand market uncertainties.
By Susan Kelly • Jan. 5, 2021 -
Samantha Liss, Healthcare Dive
Healthcare cyberattacks spiked 45% since November, report finds
While most ransomware attacks a broad sector, Check Point found Ryuk is tailored toward targets in the healthcare industry.
By Samantha Schwartz • Jan. 5, 2021 -
Brexit deal creates regulatory barriers to UK-EU medical device trade
The new arrangement lacks provisions for the mutual recognition of standards, forcing products made in the U.K. to undergo an extra certification step to enter the EU market.
By Nick Paul Taylor • Jan. 4, 2021 -
Medtronic, J&J and Edwards among medtechs to headline at JP Morgan
Players in the COVID-19 diagnostic sector and red-hot liquid biopsy space are also set to present, making the event a chance to assess the state of the industry as it tries to move on from a turbulent 2020.
By Nick Paul Taylor • Jan. 4, 2021 -
Adobe Stock
The top medtech deals of 2020 (and one that got away)
M&A activity bounced back in the second half of the year, with deals ranging from Teladoc's $18.5 billion Livongo buy to Stryker's drawn-out $4 billion acquisition of Wright Medical.
By Susan Kelly • Jan. 4, 2021 -
Permission granted by The Boldt. Co.
Hospital finances bleak as 2020 nears a close, Kaufman Hall says
As COVID-19 cases keep rising, both hospitals and medical device companies face economic challenges early next year.
By Hailey Mensik • Dec. 23, 2020 -
Jacob Bell / BioPharma Dive
FDA 2020 recall roundup: A rough year for infusion pumps
The agency listed a total of nine entries for recalls of infusion pumps or components and one update of an earlier action, for models made by Baxter, BD, CME America and Smiths Medical. BD's Alaris line accounted for half.
By Susan Kelly • Dec. 23, 2020 -
Getty / edited by Healthcare Dive
Hospital giant Tenet goes big on ASCs
A shift in focus to outpatient settings is also occurring among medical device companies. Both Stryker and Zimmer Biomet have made ASCs more of a priority over the last several years.
By Samantha Liss • Dec. 22, 2020 -
Notified bodies warn MDR certification bottleneck could lead to medical device shortages
With more than 7,000 certificates set to expire in 2024, Team-NB wants the European Union to act now by allowing remote audits under the Medical Device Regulation.
By Nick Paul Taylor • Dec. 21, 2020
Previous
