Cybersecurity Bill Draws Support From Healthcare Security Specialists September 12, 2017 A recently introduced cybersecurity bill for medical devices is attracting some support — at least from the medical community. Read More
Migraine Treatment Device Wins Marketing Clearance September 12, 2017 Devicemaker eNeura received 510(k) clearance from the FDA for the eNeura Spring TMS for treatment of migraine headache. Read More
DHS Issues Advisory on Cyber Vulnerabilities in Infusion Pump September 12, 2017 The vulnerabilities could allow a hacker to gain unauthorized access. Read More
FDA Warns Monitor Manufacturer Over Unapproved Use September 12, 2017 The FDA cleared the Eye-Sync as a prescription device to identify visual impairment, not head injuries. Read More
Judge Dismisses Whistleblower Lawsuit Against Boston Scientific September 12, 2017 The company began selling the defibrillators in Europe in February 2008, and doctors soon reported difficulties in securely implanting them. Read More
ClaroNav Wins FDA 510(k) Clearance for NaviENT Surgical Navigation System September 11, 2017 The device helps surgeons avoid complications during surgery. Read More
German Notified Body Extends Deadline for MEDDEV Rev. 4 Implementation September 11, 2017 The guideline promotes a common approach for EU notified bodies to undertake conformity assessments for CE marking. Read More
Australia Issues Update on Medical Device Reform September 11, 2017 The TGA reforms will enhance post-market surveillance and improve the integration of pre- and post-market activities. Read More
J&J’s Ethicon Hit With $57 Million Verdict in Pelvic Mesh Case September 11, 2017 The damages awarded are greater than those won by plaintiffs in 4 previously tried cases in Philadelphia. Read More
FDA Hits Healthline Medical Products for Numerous Deficiencies September 8, 2017 The firm’s records of complaint evaluations did not consistently include all relevant details of the complaint and the investigation. Read More
FDA Flags Florida Facility for CAPA Procedures, Complaints September 8, 2017 The complaint files lacked key information. Read More
C4 Imaging Receives Additional FDA 510(k) Clearance for its Positive-Signal MRI Marker September 8, 2017 The company assessing plans to supply Sirius for prostate cancer patients in markets outside the US. Read More