Medical Devices: Page 91
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Retrieved from Baxter.com on July 26, 2022
Baxter recalls Abacus pharma compounding software over risk of labeling errors
The FDA classified the recall as a Class I event and warned that inaccurate labels could seriously harm patients.
By Peter Green • July 26, 2022 -
GE expects supply chain issues to ease in second half after Q2 challenges for health unit
The company’s healthcare unit grew revenue by 1% year over year last quarter, while profit was down 19% compared to the second quarter of 2021.
By Ricky Zipp • July 26, 2022 -
Explore the Trendlineâž”
Permission granted by Boston Scientific
TrendlineNew medical devices are reshaping the medtech industry
From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.
By MedTech Dive staff -
Drew Angerer via Getty Images
Philips and U.S. Justice Dept. in consent decree talks on sleep apnea, ventilator recall
The company made the announcement Monday during a second-quarter earnings call but provided few details.
By Ricky Zipp , Elise Reuter • Updated July 25, 2022 -
Patrik Stollarz / Staff via Getty Images
Philips shares hit 10-year low as supply chain challenges weigh on revenue
Sleep apnea machine recall adds to woes as sales forecast is slashed for remainder of 2022.
By Elise Reuter • July 25, 2022 -
Permission granted by iRhythm Technologies
iRhythm, Alphabet unit Verily get FDA clearances for Zio Watch and software system
Bolstered by an AI algorithm, the companies’ partnership is a step closer to catching up with the Apple Watch.
By Ricky Zipp • July 25, 2022 -
VCG / Stringer via Getty Images
Intuitive's da Vinci placements dropped in Q2 due to 'choppy' supply chain, tighter spending by hospitals
CEO Gary Guthart said the larger economic trends that pressured the company in the second quarter are poised to continue.
By Ricky Zipp • July 22, 2022 -
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Smiths Medical's recall of syringe infusion pumps labeled Class I event after injuries, death
The company is asking customers to return devices if abnormal circuit board behavior causes the pump to stop.
By Nick Paul Taylor • July 21, 2022 -
Getty Images
AbbVie agrees to pay $60M for rights to acquire implantable glaucoma device
The biotech company said the deal is an opportunity to grow its eye-care business.
By Elise Reuter • July 20, 2022 -
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FDA patient advisers grapple with consent, oversight of virtual-reality devices in healthcare
The advisory group addressed patient consent in surgeries using augmented reality tools and how to distinguish clinical uses of virtual reality from entertainment products.
By Elise Reuter • July 20, 2022 -
Courtesy of Abbott
Abbott's Q2 sales boosted by COVID-19 testing; outlook for diagnostics demand remains uncertain
The company’s $2.3 billion in COVID-19 testing sales beat J.P. Morgan and Stifel analysts’ estimates by about $1 billion, while CEO Robert Ford cautioned that forecasting demand remains challenging.
By Ricky Zipp • July 20, 2022 -
Sarah Silbiger via Getty Images
Defibrillators, chest drains added to FDA's list of device shortages
The defibrillator supply disruption reflects both increased demand and problems sourcing a component, part or accessory.
By Nick Paul Taylor • July 20, 2022 -
Mario Tama/Getty via Getty Images
J&J lowers full-year sales forecast amid rising inflation, currency pressures
Despite foreign-exchange pressures, analysts said the results were an “encouraging starting point” as medtech companies begin reporting their quarterly earnings.
By Elise Reuter • July 19, 2022 -
Permission granted by iRhythm Technologies
iRhythm says Q2 unit volumes beat forecast, names Chad Patterson as new CCO
The company noted the results are preliminary and may change before its Aug. 4 earnings call.
By Ricky Zipp • July 19, 2022 -
Justin Sullivan via Getty Images
Hologic's stock rating cut by BTIG amid worsening supply chain challenges, drop in COVID testing
The company is facing challenges including increasing operating expenses and shortages of semiconductor chips, according to the analyst report.
By Ricky Zipp • July 18, 2022 -
Carl Court via Getty Images
Notified bodies have yet to issue MDR certificates for 85% of legacy devices: survey
The EU's Medical Device Regulation certification process is taking twice as long as the old directive pathway and smaller companies are struggling to get started, the poll shows.
By Nick Paul Taylor • July 18, 2022 -
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FDA faces furloughs if Senate misses August deadline for user fee bill
If legislation isn’t passed before the August recess, the FDA would have to furlough workers, slowing its review of medical device and pharmaceutical products.
By Elise Reuter • July 15, 2022 -
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Medtronic warns European healthcare providers of safety problem in defibrillators
The warning adds to Medtronic’s growing list of product safety issues over the last 18 months.
By Ricky Zipp • July 15, 2022 -
Mario Tama/Getty via Getty Images
Abbott, Intuitive, J&J to kick off quarterly earnings season next week as recession threat looms
Earnings results are poised to set expectations for the impact of a potential slowdown and shed light on trends with implications for companies including Boston Scientific, Medtronic and Stryker.
By Nick Paul Taylor • July 15, 2022 -
Spencer Platt via Getty Images
With medtech shares down 30%, investors worry about inflation, staffing shortages: William Blair
Data suggests earlier pessimism about the sector could drive stocks to outperform major indices later this year.
By Elise Reuter • July 14, 2022 -
Mario Tama/Getty via Getty Images
Rising procedure volumes boost hopes for Abbott, J&J as orthopedics lag, survey finds
Stifel analysts see the findings as positive for Abbott, J&J and Intuitive and supportive of Edwards and Medtronic’s TAVR targets. The survey comes just before the medtech industry reports its latest earnings.
By Nick Paul Taylor • July 14, 2022 -
Courtesy of Abbott
Abbott gets FDA breakthrough tag for deep brain stimulation system in depression
The breakthrough device designation builds on a series of clinical trials of other systems that have yielded mixed results.
By Nick Paul Taylor • July 13, 2022 -
Permission granted by CathWorks
Medtronic lands option to buy artery disease player CathWorks for up to $585M
CathWorks has the right to compel Medtronic to complete the acquisition if it chooses not to exercise its option.
By Nick Paul Taylor • July 13, 2022 -
Getty Images
Faulty oximeter readings led to racial, ethnic disparities in treatment: study
Researchers previously noted that the devices may be less accurate when used by people with darker skin, and a recent study found the difference led to patients failing to receive needed treatment.
By Elise Reuter • July 12, 2022 -
Alex Wong via Getty Images
CMS makes 'market-moving proposals' to some medtech Medicare rates, say analysts
BTIG analysts warned in a recent report that the changes “might curtail usage of some higher-dollar” medical devices.
By Nick Paul Taylor • July 12, 2022 -
Carl Court via Getty Images
European Commission targets spring of 2024 for fully functional Eudamed database
The Commission is planning a two-phase transition to mandatory use of the database after it goes live.
By Nick Paul Taylor • July 11, 2022
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