GE (NYSE:GE) is warning investors that supply and labor shortages are squeezing its Healthcare business this quarter, and that the pressure won’t likely let up in 2021.
GE’s Healthcare business “largely is a supply chain story right now,” GE Chair and CEO Larry Culp said this week, specifically citing semiconductors, resin and logistics as supply chain barriers to meeting “strong, if not robust” demand.
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The Alfred E. Mann Foundation for Scientific Research (AMF) today announced the sale of intellectual property to Medtronic (NYSE:MDT).
As part of the transaction of IP related to implanted infusion pumps, AMF will work with Medtronic to develop the technology into a next-generation implantable insulin pump for people living with hard-to-treat type 1 diabetes in Europe.
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Genomic and diagnostic testing company Prenetics announced that it will merge with Artisan Acquisition Corp. and go public.
Artisan, a special purpose acquisition company (SPAC) will provide a business portfolio across retail, hospitality, healthcare, property and other strategic businesses for Prenetics to substantially expand its platform through the merger, according to a news release.
The transaction values Prenetics at approximately $1.25 billion with a combined equity value of approximately $1.7 billion. The Hong Kong- and UK-based diagnostics company says it projects 215% revenue growth year-on-year from $65 million last year to $205 million in 2021. Its 2025 revenue projections total more than $600 million.
Prenetics most recently launched Circle HealthPod in Hong Kong, a CE-IVD point-of-care diagnostic and at-home rapid detection health monitoring system for infectious diseases, starting with COVID-19. The R&D team is developing tests for in…
Diabeloop announced today that it set up a local and dedicated team to support its pursuit of entry into the U.S. market.
Paris-based Diabeloop develops an automated insulin delivery (AID) system that deployed throughout Europe this past year, making it commercially available in Germany, the Netherlands, Italy, Spain and Switzerland, with more countries to come. The interoperable controller can be used recombination with the Dexcom G6 CGM and Accu-Chek Insight insulin pump and will soon be available with ViCentra’s patch-like Kaleido pump.
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Digital surgery platform developer Caresyntax announced today that it added a $30 million extension to its Series C funding round.
Boston-based Caresyntax’s $30 million extension brings its total Series C funding to $130 million, adding to the first stage announced in April 2021, according to a news release.
PFM Health Sciences led the extension, with selected investors including funds and accounts managed by BlackRock, as well as ProAssurance, Harmonix and existing investors such as the Relyens Group and IPF Partners. The overall Series C features investments from Optum Ventures, Intel Capital, Lauxera Capital Partners, Vesalius Biocapital III, Arno Capital, Rezayat Investments, and Surgical.AI.
Caresyntax said the funding will be used to continue developing its digital surgery platform, which uses proprietary software and AI to analyze large volumes of real-world data in and around the operating room to offer insights for immediate use by…
CMS intends to kill the Medicare Coverage of Innovative Technology (MCIT) program that would have accelerated government payments for medical devices designated by the FDA as breakthroughs.
CMS (the U.S. Centers for Medicare & Medicaid Services) disclosed its proposal in the Federal Registrar yesterday — three months before the rule was set to take effect on Dec. 15 — saying the rule “is not in the best interest of Medicare beneficiaries.”
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Pear Therapeutics today announced the publication of positive results from real-world data of its reSET-O prescription digital therapeutic.
Boston-based Pear Therapeutics evaluated its FDA-authorized reSET-O PDT in the treatment of opioid use disorder (OUD) on patients treated for 24 weeks, with real-world evidence demonstrating that the treatment is associated with improved outcomes, high levels of treatment retention and fewer hospital encounters compared to 12 weeks of the treatment.
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Erika Cheung, a former Theranos lab associate, testified yesterday that the machines the company was using to conduct patient blood tests had inaccuracies of quality control test results that would result in inaccurate patient tests, Silicon Valley News reports. She said that some 30% of prostate cancer tests were inaccurate and thyroid tests returned with a failure rate of more than 50%.
Cheung claimed that Theranos would throw out outlier data points to get the tests to pass quality control checks, The Washington Post reports. She said choosing those outliers was like “cherry-picking” and that the …
Philip Morris (NYSE:PM) announced today that its offer to buy inhaled drug delivery technology developer Vectura has become unconditional.
Having received valid acceptances for or acquired 74.77% of Vectura shares, in excess of the 50% required under the acceptance condition, along with confirming that all other conditions to the offer have been satisfied or waived, the deal reached unconditional status.
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Smiths Medical is recalling the Normoflo irrigation fluid warmer and warmer sets due to the potential for aluminum ions leaching into warmed fluids.
The recall has been designated as a Class I recall — the most serious kind — by the FDA.
According to an FDA notice, when fluid circulates through a patient’s body, the patient can be exposed to high levels of aluminum. That exposure may not be easily recognized and could lead to serious adverse events, including death. No complaints, injuries or reports of death have been received to date.
The recall covers the Normoflo irrigation fluid warmer and Normoflo irrigation warming set. The company initiated the recall on Aug. 6, 2021, for devices manufactured between January 1994 and July 2021 and distributed between January 1994 and the present day. To date, Smiths Medical has recalled 520,163 devices in the U.S.
Normoflo fluid warming systems warm blood, blood products and intravenous solutions bef…
Facing the second-biggest wave of COVID-19 infections and waning popularity, President Biden has promised to launch an initiative to begin providing vaccine boosters starting September 20.
But the plan hinges upon FDA and CDC support, and some officials at the agencies remain unconvinced that boosters are immediately necessary.
Two departing senior FDA vaccine officials recently co-wrote an article published in The Lancet arguing that insufficient evidence exists to justify the case for boosters. “Even if boosting were eventually shown to decrease the medium-term risk of serious disease, current vaccine supplies could save more lives if used in previously unvaccinated populations than if used as boosters in vaccinated populations,” the paper argues. In addition, while the public could ultimately benefit from boosting, administering boosters before they are required could lead to an uptick in adverse events, according to The Lancet art…
InTRAvent has announced FDA 510(k) clearance of its Solopass system for assisting frontal placement of intraventricular catheters deep within the brain.
The Hershey, Pennsylvania-based company said yesterday that it designed the device with 2D and 3D ultrasound imaging, artificial intelligence and trajectory guidance for intraprocedural localization and navigation for external ventricular drain (EVD) placement.
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