The Latest
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Medtronic issues Class I recall of implantable cardioverter defibrillators in U.S.
The devices may deliver a reduced shock during high-voltage therapy, about 79% of the programmed energy.
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As monkeypox cases increase, disease experts lament lack of testing access
“It’s the same problem that happened with COVID-19. This is exactly identical,” said Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security in Baltimore.
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Roundup: Medical device industry confident it can ride out recession, wary of slowing capital sales
While companies may weather a recession, they still face challenges like hospital staffing shortages, supply chain disruption and inflation, RBC Capital Markets analysts wrote.
Updated Aug. 10, 2022 -
Boston Scientific says it’s investigating allegations of anti-bribery law violations
The company says the issue is centered on its operations in Vietnam.
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Eargo’s Q2 revenue slides amid decline in hearing-aid shipments
The company’s gross system shipments fell by more than 8,000 when compared to the year-earlier period.
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BD begins tender offers for up to $500M in debt to advance repayment strategy
The spinoff of the diabetes business to form Embecta has provided proceeds that BD plans to use to pay down $1 billion in debt, according to Fitch Ratings.
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FDA’s hearing-aid guidance clears regulatory review amid push by lawmakers for OTC sales
The move comes after the agency proposed the creation of a new category of over-the-counter hearing aids in October.
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FDA’s breakthrough device designations poised for another record year
At the midpoint of the year, the FDA had granted 129 designations, suggesting it will break the previous full-year record of 206.
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Senate passes $740B bill to lower healthcare costs after months of wrangling
While Republicans successfully challenged a planned $35 insulin price ceiling for patients on private insurance, the law still has implications for makers of diabetes devices.
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Q&A
Friday Q&A: FDA’s former medical device cybersecurity director says more investment needed in staffing
The FDA and medtech companies will need more cybersecurity staff to stay ahead of hackers, says Kevin Fu, who is now focused on building that workforce for the government, private sector and academia.
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iRhythm raises 2022 revenue forecast after record number of registrations in Q2
The cardiac monitor maker increased the low end of its forecast by $5 million, although executives expect a flat third quarter compared to the second quarter due to macroeconomic pressures.
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QuidelOrtho reports 37.5% sales growth in first quarter since $6B merger
The testing firm is increasing sales after Quidel merged with Ortho, opening opportunities to cut costs and increase point-of-care and molecular diagnostics revenue.
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EPA. (2022). "https://www.epa.gov/hazardous-air-pollutants-ethylene-oxide/forms/columbus-nebraska-becton-dickinson-pharmaceutical" [Photo]. Retrieved from EPA.gov.
EPA names BD, Edwards and Medtronic on list of higher-risk sterilization facilities
AdvaMed said ethylene oxide is vital for prevention of serious infections and shutting facilities could disrupt the supply of medical devices.
Updated Aug. 5, 2022 -
Biden administration declares monkeypox a public health emergency
Federal health officials said Thursday that U.S. monkeypox testing capacity is at about 80,000 tests per week, although only 10% of capacity is currently being used.
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SEC accuses surgical implant business of pulling forward sales to hit targets
According to the SEC, Surgalign, known at the time as RTI Surgical, shipped future orders ahead of schedule to pull forward revenues and mask disappointing sales figures.
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BD’s base business growth in Q3 offset by drop in COVID-19 testing
The company reported a year-over-year drop of about $224 million in COVID-19 testing revenue compared to 2021, with the testing slowdown expected to continue.
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ResMed buys Mementor for prescription digital health app, continuing German expansion
ResMed will integrate the startup into its German operation as a separate business segment and use it as a platform for further digital health development.
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6 questions for the medtech industry if Congress doesn’t reauthorize FDA user fees on time
If Congress doesn’t pass the legislation before Sept. 30, furloughs and delays lie ahead for the agency.
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Hospitals have low level of accountability for connected device breaches
Of the 43% of organizations that reported a data breach in the past two years, 88% said at least one connected device was a contributing factor to the breach, according to a new report.
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Retrieved from Siemsens Website on July 01, 2022
Siemens Healthineers stumbles as lockdowns, falling COVID-19 sales and rising costs hit business
Lockdowns in China caused a steep decline in equipment orders and a big setback to the firm’s core diagnostic business, even as the company expects to meet full year revenue targets.
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Credit NASA. (1989). "STS-34 crewmembers conduct DSO 0470 on OV-104's middeck" [Photo]. Retrieved from NASA.
Virtual Incision opens new frontier for robotic surgery with space station mission
Using a grant from NASA, the company will perform a mission on the International Space Station to show its platform’s suitability for long-duration space travel.
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Illumina vows to fight EU efforts to block $8B Grail merger
Illumina acquired the liquid biopsy company in 2021, despite pending anti-competitiveness investigations on both sides of the Atlantic.
Updated Aug. 2, 2022 -
Zimmer Biomet raises revenue forecast on faster-than-expected COVID recovery
The company saw sales across knee and hip procedures increase, though it still faces foreign currency and supply chain challenges.
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Boston Scientific pays $85M to settle long-running patent dispute with Nevro
J.P. Morgan analysts said the settlement over spinal cord stimulation devices is “a dollar win for Nevro, but a longer-term competitive loss.”
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North American Diagnostics latest to recall COVID-19 tests, gets Class I label from FDA
The recall adds to a list of medtech firms that have been forced to withdraw illegally distributed COVID-19 tests, amid concerns they could yield false results.