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In an effort to deepen Ohio’s biotech footprint, a state economic development initiative is pouring more $12.8 million into cutting-edge biomedical companies, startups and entrepreneurs to support innovation in the state. Read More
Sharplight Technologies, an Israeli maker of powered surgical lasers, received an FDA warning letter for failures with quality records and other documents. Read More
The FDA will soon begin identifying candidates for a pilot program whereby manufacturers can opt to self-identify and correct possible regulatory violations and avoid FDA inspection. Read More
San Up, a Buenos Aires maker of piston and ultrasonic nebulizers, was warned by the FDA after cleaning shortfalls and other good manufacturing practice slip-ups. Read More
A proposed policy that would allow hospitals to set their own maintenance schedules for medical equipment could pose a significant risk to users of imaging and radiological devices, a coalition of medical societies says. Read More
At the close of a comment period on the quality management systems reporting burden for devicemakers, the FDA received just one reply requesting a few clarifications. Read More
A bill to regulate medical apps according to risk continues to spark debate, with supporters saying it is needed to protect innovation and detractors saying it is premature. Read More
Synecco, a China-based contract manufacturer and contract sterilizer, received an FDA warning letter for shortfalls in sterilization validation and other GMP issues. Read More
An FDA review of Mectra Labs’ website found that the company was offering a new size of its MAGI and ALIEN insufflation needles without clearance or approval, prompting a warning letter. Read More
Avacen, maker of The Avacen Thermal Exchange System (TATES), was hit with a nine-citation FDA warning letter for failing to establish a host of essential GMP procedures. Read More
An FDA investigator handed Chase Medical a Form 483 after the company’s manufacturing assembler admitted she does not always remember to document all in-process tests for the Tripod Heart Stabilizer devices. Read More
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