Devices
FDA has cleared a Medi-Lynx Cardiac Monitoring 510(k) for the PocketECG Cardiac Rehabilitation System, a mobile cardiac rehabilitation designed to provide ECG monitoring and automated arrhythmia detection during rehabilitation training. The smartphone-sized device is intended to monitor a patient’s heart rhythm and heart rate during rehabilitation
Devices
FDA has cleared a NeuMoDx Molecular 510(k) for its NeuMoDx 288 Molecular System and its NeuMoDx GBS [Group B Streptococcus] Assay. “The fully automated NeuMoDx 288 Molecular System is the first offering in a family of scalable platforms that integrate the entire diagnostic process – from extraction to detection or
Devices
Bayer has decided to stop marketing its controversial Essure permanent birth control device, effective 12/31. The company’s move follows an April FDA patient safety action, in which the agency issued an order restricting the sale and distribution of Essure (see story). “For women who have received an Essure
Devices
FDA has cleared an Adaptiiv 510(k) for its 3D Bolus Software for use in creating customized personal medical devices using 3D printing, primarily for use in treating cancer. The software allows practitioners 3D printing of patient-specific uniform thickness bolus, modulated bolus for MERT (modulated electron radiation therapy), High-
Devices
GE Healthcare calls on FDA to continue to employ a risk-based approach to regulating software products, differentiating not only between functions that are not medical devices and those that remain medical devices, but also including a category of products that, based on risk, warrant exercising enforcement discretion. The company’
Drugs
Washington Legal Foundation (WLF) challenges the FDA position that its proposed product jurisdiction rule is intended to merely clarify existing regulations and update them to reflect agency practices and procedures. “WLF respectfully submits that the proposed rule accomplishes neither objective,” its comment letter says. “Nor has FDA taken this opportunity
Drugs
FDA has published a guidance, Use of Electronic Health Record Data in Clinical Investigations, to assist sponsors, clinical investigators, contract research organizations, institutional review boards, and other interested parties in using electronic health record (EHR) data in FDA-regulated clinical investigations. The document defines electronic health systems for its purposes
Drugs
Cook Group says it believes that an FDA proposed rule on product jurisdiction will assist the agency to achieve its public health mission. Its comment letter requests clarifications or changes to the proposal’s language on clarifying the scope of the regulations, streamlining and clarifying the appeals process, aligning the
FDA Policy/General
FDA has published a report summarizing the major points explored with stakeholders at a 4/16 public workshop on “Evaluating Inclusion and Exclusion Criteria in Clinical Trials.” The report says the workshop “provided an opportunity for representatives from academia, industry, healthcare delivery, government, and patient advocacy groups to discuss a
Devices
BAROnova has submitted a PMA for the TransPyloric Shuttle device intended for treating obesity. The device is trans-orally placed in the stomach during a standard endoscopic procedure and is intended to reside in the stomach for 12 months after which it is endoscopically removed. Its primary mechanism of action
Devices
FDA has published a draft guidance, Metal Expandable Biliary Stents-Premarket Notification (510(k) Submissions, to receive stakeholder comments on draft recommendations for 510(k) submissions for metal expandable biliary stents and their associated delivery systems. The document says devices are intended to provide luminal patency of the biliary tree.
Devices
FDA has approved a Stryker PMA for the Surpass Streamline Flow Diverter to treat unruptured large and giant wide neck intracranial aneurysms. The device is indicated for unruptured aneurysms which are more challenging due to their location and surrounding anatomy, according to the company. “The stent is designed to reliably
Devices
FDA has cleared a Quidel Corp. 510(k) for the Solana Bordetella Complete Assay, a molecular diagnostic assay to be used with the Solana molecular diagnostic instrument for the qualitative detection and differentiation of Bordetella pertussis and Bordetella parapertussis nucleic acids isolated from nasopharyngeal swab specimens obtained from patients suspected
Devices
AdvaMed says that if properly defined and implemented, a proposed new 510(k) expanded pathway “potentially complements the current 510(k) pathways, all of which assure that patients have timely access to safe, effective, and high-quality medical devices.” The trade group expresses a concern that an expanded abbreviated 510(
Devices
FDA has cleared a Companion Medical 510(k) for an Android version of its InPen app, clearing the way for release of the first smart pen system for Android users. The InPen system has been commercially available for Apple operating system users since 12/2017 and it is the only
Devices
FDA has approved Abbott’s next-generation MitraClip heart valve repair device used to mend a leaky mitral valve without open-heart surgery. It is designed to “allow for more precise placement during deployment, resulting in more predictable procedures, and additionally offers a second clip size with longer arms that
Devices
BioElectronics has submitted a 510(k) for ActiPatch and its over-the-counter adjunctive use in treating musculoskeletal pain. The device is currently cleared for adjunctive treatment of pain from knee osteoarthritis and plantar fasciitis. The expanded market clearance would allow for additional use for the back, neck, hip, shoulder,
Drugs
In 12 years on the DC Court of Appeals, Supreme Court nominee Brett Kavanaugh has helped decide some cases in favor of FDA, while ruling against the agency in others. A Stat News analysis reports that Kavanaugh was part of an 8-2 majority when the appeals court upheld a
Drugs
FDA has published three new draft guidances on development of gene therapy products for specific diseases. The agency also has released new and comprehensive updates to three existing guidances that address manufacturing issues related to gene therapy. A statement from FDA commissioner Scott Gottlieb (includes links to all six guidances)
Devices
FDA has approved a Medtronic PMA for a less-invasive implant approach for its HVAD System, a left ventricular assist device (LVAD) for patients with advanced heart failure. The device is the only LVAD approved in the U.S. for implant via thoracotomy, a small lateral surgical incision between the
Drugs
The Department of Justice has launched a Task Force on Market Integrity and Consumer Fraud authorized under an Executive Order signed by President Trump to focus on combating fraud against consumers — particularly the elderly, service members, and veterans — and corporate fraud that victimizes the general public and the government. Deputy
Devices
FDA has cleared a Zebra Medical Vision 510(k) for its Coronary Calcium Scoring algorithm for automatically calculating a patient’s Agatston equivalent coronary calcium score from ECG gated CT scans. “Zebra’s algorithm could run on CT studies of the chest and potentially help identify people with cardiovascular risk