Techlab Wins FDA Clearance for E. Histolytica Quik Chek Device June 13, 2017 The assay specifically detects pathogenic E. histolytica. Read More
FDA Planning Phased Transition to New Cures Act Drug Development Tool Qualification Scheme June 13, 2017 The tool qualification process includes three requirements from the sponsor. Read More
Milestone Scientific Gains FDA Clearance for CompuFlo Epidural Instrument June 12, 2017 The device allows for anesthesiologists to quantitatively determine and document the pressure at the needle tip in real time. Read More
FDA Warns Compounder Over Unsterile Procedures, GMP Failures June 12, 2017 FDA investigators said Ranier’s did not receive valid prescriptions for individuallyidentified patients for a portion of the products. Read More
Medical Device Security is Deeply Lacking, Says New Study June 9, 2017 The study included responses from about 550 individuals with security roles. Read More
FDA Cites Yusef Labs for Inadequate Investigations, Quality Concerns June 9, 2017 The agency faulted the company for failing to investigate discrepancies. Read More
FDA Clears Thornhill Medical's Portable Emergency Life Support System June 8, 2017 The system has a built-in oxygen concentrator. Read More
GSK and ViiV Healthcare Use $130 Million Priority Review Voucher to Expedite HIV Therapy June 8, 2017 The companies recently acquired the voucher for $130 million, but did not disclose the seller. Read More
FDA Awards Marketing Clearance to Eko’s Heart Monitor June 7, 2017 The Duo is a handheld screening tool. Read More
Express Scripts Claims ‘Profiteering’ in Suit Against Overdose Treatment Manufacturer June 7, 2017 The lawsuit claims Kaleo owes administrative fees that increased at the same time as Evzio’s prices. Read More
Boston Scientific Wins CE Mark for the Vercise Primary Cell Deep Brain Stimulation System June 6, 2017 The device provides DBS therapy. Read More
Cleanroom Problems Found in Compounder Inspection June 6, 2017 Inspectors also found deficiencies in cleanliness and sterility at the outsourcing facility. Read More