FDA clears Masimo’s over-the-counter Stork baby monitoring system
Masimo secured FDA clearance for its Stork baby monitoring system that can help track certain vital signs in healthy infants up to 18 months old and provide alarms to parents or caregiver…
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Continue Reading »Outset Medical rebounds on new FDA clearance for dialysis cart
Outset Medical has resumed distributing its portable dialysis machine after halting sales last summer, now that it’s obtained a new FDA green light.
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Continue Reading »Apple Watch’s afib-tracking app certified by FDA for use in clinical studies
The watch’s sensor and software marked the first digital health product to be qualified under the agency’s Medical Device Development Tools program.
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Continue Reading »This Medical Device Company Fought FDA and Won
In 1997, Myotronics became embroiled in a fight with FDA that ultimately led to disciplinary action against two agency employees and the unseating of two advisory panel members.
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Continue Reading »Labcorp nets companion diagnostic approval for Pfizer’s hemophilia B gene therapy Beqvez
The FDA has bestowed a green light to a companion diagnostic for Pfizer’s recently approved hemophilia B gene therapy—because at a cost of $3.5 million per dose, you want to make sure it will work.
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Continue Reading »Philips signs $1.1B settlement in CPAP recall injury litigation, takes $578M insurance payout
Philips has reached an $1.1 billion agreement to settle claims from about 58,000 people stemming from its yearslong recall of sleep apnea machines.
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Continue Reading »3D Systems’ FDA clearance for 3D-printed PEEK cranial implants
FDA clearance enables wide-spread adoption of 3D Systems self-contained, cleanroom environment-based printing system, the EXT 220 MED, with medical-grade PEEK materials to deliver patient-specific cranial reconstruction solutions.
Read the full article at: www.todaysmedicaldevelopments.com
Continue Reading »Roche picks up Prenosis’ newly cleared sepsis AI tool for distribution
Following last week’s de novo clearance for the AI program, Roche has stepped up to distribute Prenosis’ sepsis risk prediction tool through its diagnostic platforms.
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Continue Reading »In Vitro Diagnostics (IVD) Market Size Could Reach USD 120.49 Billion by 2033
According to Report, the global in vitro diagnostics (IVD) market size is calculated at USD 77.96 billion in 2023 and it is increasing over USD 120.49 billion by 2033, growing at a CAGR of 4.45% from 2024 to 2033.
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Continue Reading »Making an Impact in the Growing Vessel Closure Market
Recent approvals in the TAVR and TMVR markets are providing significant opportunities for companies like Vivasure Medical.
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