Biologics
The Biotechnology Innovation Organization (BIO) says it appreciates efforts by CDRH and CBER to develop a guidance on patient-reported outcome (PRO) instruments for use in medical product evaluation. BIO’s comment letter says that while PROs are an important tool for collecting and reporting patient experiences, the trade group
Devices
A 10/19 CDRH Webinar listening session explained the “roadmap” governing the new Digital Health Center of Excellence (DHCoE) and heard comments from stakeholders. DHCoE director Bakul Patel said the organization’s goal is to empower digital health stakeholders to advance healthcare. “We believe digital health has the potential to
Devices
Medtronic has begun a Class 1 recall of its Rashkind Balloon Septostomy Catheters because of device quality issues that may lead to the device breaking, separating or failing during use. If this occurs, use of the affected product may cause serious injuries, such as damage to blood vessels and death,
Devices
FDA says clinical laboratory staff and healthcare providers should be aware that false positive results can occur with antigen tests, including when users do not follow the instructions for use of antigen tests for the rapid detection of SATS-CoV-2. An agency statement says laboratories “should expect some false
Devices
FDA has approved Boston Scientific’s Ranger Drug-Coated Balloon for treating patients with peripheral artery disease (PAD) in the superficial femoral artery (SFA) and proximal popliteal artery (PPA). The company says the device was designed with a “low therapeutic drug dose and proprietary coating which efficiently transfers the drug
Devices
The Western Michigan District Court has sentenced Roger D. Beyer to 57 months in federal prison for his involvement in a conspiracy to commit healthcare fraud and 12 months concurrently for the adulteration of medical devices. Beyer previously owned and operated Urological Solutions of Michigan, a mobile medical practice providing
Devices
Medtronic has agreed to pay $8.1 million to resolve allegations that it violated the False Claims Act by paying kickbacks to induce a South Dakota neurosurgeon to use certain Medtronic products. The company also agreed to pay an additional $1.11 million to resolve allegations that it violated the
Biologics
FDA has entered into a Cooperative Research and Development Agreement with Emulate, Inc., to enable multiple studies across FDA Centers in priority research areas, including programs to evaluate Covid-19 vaccines and understand human response against SARS-CoV-2. Emulate says that under the agreement the agency will use a
Devices
Attorney Michael Kasser (Hogan Lovells) says that the use of nitinol by medical device manufacturers “significantly increases the amount of bench testing that will be required to obtain marketing clearance.” In an online post, Kasser says a recently finalized FDA guidance on medical devices that contain nitinol details the corrosion
Devices
FDA says Baxter has issued an urgent device correction to reinforce safety information on cleaning practices for all Sigma Spectrum infusion pumps. The 10/28 notice says that deviations from the specified cleaning methods may impair infusion pump functionality and performance. The company says it communicated the information to customers
Devices
CDRH will be seeking a boost to its resources as it negotiates the reauthorization of the Medical Device User Fee Act (MDUFA) program. During a 10/27 public meeting on reauthorizing the user fees, FDA commissioner Stephen Hahn acknowledged the resource strain from the current Covid-19 emergency on the
Drugs
FDA has published a guidance, Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products, to give sponsors recommendations on the nonclinical information to support the development and approval of orally inhaled nicotine-containing drug products, including electronic nicotine delivery systems intended for smoking cessation and related chronic indications. The document
Devices
FDA has released a summary of the 10/22 Patient Engagement Advisory Committee meeting called to discuss and make recommendations on artificial intelligence and machine learning (AI/ML) in medical devices. The summary says the committee discussed the composition of the datasets on which the software “learns,” components of the
Devices
FDA has posted a revised guidance entitled Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (Covid-19) Public Health Emergency. The document expands the availability and capability of remote patient monitoring devices that may increase access to patient physiological data
Devices
FDA’s Circulatory System Devices Advisory Panel has voted 13 to 3 against recommending PMA approval for Neovasc’s Reducer for treating patients with refractory angina pectoris despite guideline-directed medical therapy, and who are unsuitable for revascularization by coronary artery bypass grafting or by percutaneous coronary intervention. Several committee
Devices
FDA says it will not enforce compliance with the PMA requirements for necessary automated external defibrillator (AED) accessories (such as batteries, pad electrodes, adapters, and hardware keys for pediatric use) until 2/3/22. An agency guidance, Necessary Automated External Defibrillator Accessories: Policy Regarding Compliance Date, says the delayed enforcement
Devices
FDA has granted Abiomed 510(k) clearance for an all-in-one, compact cardiopulmonary bypass system called the Abiomed Breethe OXY-1 System. The device provides cardiopulmonary bypass support for patients whose lungs can no longer provide sufficient end organ oxygenation. It is intended to pump, oxygenate, and remove carbon
Devices
FDA has approved a Medtronic PMA for its Abre venous self-expanding stent system. The device is indicated for use in the iliofemoral veins in patients with symptomatic iliofemoral venous outflow obstruction (also known as deep venous obstruction). “If left untreated, patients can experience leg discomfort and pain, limiting their
Devices
FDA has revised its template that provides current recommendations about data and information that should be submitted to support a pre-Emergency Use Authorization submission for a Covid-19 antigen test. The template is intended to help test developers provide validation data and other information, but it says alternative approaches
Devices
CDRH officials are looking to identify the least amount of information that device companies need to support a declaration of conformity to a recognized standard. During a 10/15 Web cast (see transcript) on the Center’s recently issued final guidance on Recognition and Withdrawal of Voluntary Consensus Standards, CDRH
Devices
FDA has granted Neuro Event Labs a breakthrough device designation for its Nelli, a device designed to automate the identification of seizure events using video, audio and sophisticated software algorithms through artificial intelligence. “With Nelli, patients don't have to wear anything,” the company says. “They just have to
Devices
FDA has approved Avioq’s VioOne HIV Profile Supplemental Assay, an enzyme-linked immunosorbent assay for confirmation and differentiation of individual antibodies directed to various gene products of HIV-1 (Group M & Group O) and HIV-2 in human serum or plasma. The company says the assay is intended