Devices
FDA has cleared a Med-El USA 510(k) for its next generation non-surgical bone conduction hearing technology called AdHear. The adhesive adapter is placed onto the skin behind the ear and is worn for three to seven days at a time. A lightweight audio processor is clicked on
Devices
FDA has approved Medtronic’s Infuse Bone Graft in new spine surgery indications. The device is now approved for use with additional spine implants made of polyetheretherketone in oblique lateral interbody fusion and anterior lumbar interbody fusion procedures. Infuse is intended to be used with certain Medtronic interbody fusion devices
Devices
Attorney Allyson Mullen (Hyman, Phelps & McNamara) says FDA made significant changes in the finalized 4/13 next generation sequencing guidance (NGS) without any explanation for why its thinking on the subject has changed. Writing in her firm’s FDA Law Blog, Mullen says the substantive changes in the guidance
Drugs
The American Association for Cancer Research says it has four recommendations in response to the FDA 3/15 public meeting on the structure and function of the Oncology Center of Excellence (OCE). The comment letter says (1) OCE should have clear, final signoff authority for all product reviews associated with
Devices
Cooper Union adjunct professor of biomedical engineering William Hyman says his experiment seeking information on a cardiac ablation catheter based on its unique device identifier (UDI) found that there can be too little information available. Writing in an AAMIBlog post, Hyman says FDA has said a benefit of using UDIs
Devices
FDA has cleared an Agfa 510(k) for its DR 800 multi-purpose imaging system. The device offers consolidated applications, including radiography, fluoroscopy and other advanced clinical applications, according to the company. The device comes with Dynamic MUSICA for both static and dynamic (moving) images, and the image processing software
Devices
FDA has published a draft guidance, Multiple Function Device Products: Policy and Considerations, to explain the agency’s regulatory approach and policy for all multiple function device products. The document says medical products may contain several functions, not all of which are subject to FDA regulatory oversight as medical devices.
Devices
Bayer has submitted to FDA a heavily redacted updated 12-month interim postmarket surveillance report on the company’s Essure 522 study. The company says the report was updated with the subject accrual completion date, the Bayer regulatory contact information, and one new paragraph at the end of Section 3.
Drugs
Attorney Jennifer Thomas (Hyman, Phelps & McNamara) says the Supreme Court took steps this week in two False Claims Act (FCA) cases. Writing in her firm’s FDA Law Blog, Thomas says the court first invited the Solicitor General to submit a brief outlining the government’s views on a
Devices
FDA has written to healthcare providers that it is evaluating data suggesting that potentially inaccurate magnetic resonance thermometry information can be displayed during treatment with magnetic resonance-guided laser interstitial thermal therapy devices that are commonly used in neurosurgical procedures. The agency letter says the devices also may not account
Devices
Three individuals who marketed and sold over $16 million worth of light-emitting medical devices as a cure-all to consumers have been sentenced by a federal judge in Rapid City, SD. According to the Justice Department, Robert Lytle of Rapid City, who was the leader and organizer of the
Devices
Fresenius-Kabi USA has begun a mandatory software update field action for the DXT Relay 2.x because of issues identified in the software that cause it to malfunction. The issues impact the ability of procedure data to be transmitted from a collection device to the customer's electronic
Devices
FDA has cleared a Varian 510(k) for its Calypso Anchored Beacon transponder. Used with Varian’s TrueBeam, Edge and Clinac C-series medical linear accelerators, the transponder detects slight movements of a tumor and helps clinicians deliver lung stereotactic body radiotherapy. The device is implanted in small airways within
Devices
FDA has cleared a SpeeDx 510(k) for its ResistancePlus MG Positive Control kit, a diagnostic test that simultaneously detects M. genitalium and genetic markers for antimicrobial resistance. The kit contains synthetic DNA to simulate Mycoplasma genitalium, as well as five mutations known to confer resistance to macrolide antibiotics. Macrolide-
Devices
An Alabama federal court has ruled that a plaintiff’s claims against Allergan over its Lap-Band weight loss PMA device are preempted under federal law. Attorney Michelle Yeary (Dechert) writes in an online blog post that the claims the court ruled on involved negligence, failure to warn, and negligent
Devices
FDA has cleared an Arthrosurface 510(k) to market the stemless OVOMotion Shoulder Arthroplasty System that the company says is intended to provide surgeons with an approach that results in increased exposure to the glenoid, minimizes bone removal, and is designed for patients with painful or severely disabled shoulder joints
Devices
FDA is warning healthcare providers and facilities about the risk of cross-contamination with certain 24-hour multi-patient use endoscope connectors. “To date, FDA has not received acceptable testing to demonstrate the safe use of these products, and recommends against their use,” an agency notice says. The notice says
Devices
FDA has cleared a Cantel Medical 510(k) for its Advantage Plus Pass-Thru automated endoscope reprocessor. The device has been clinically proven to disinfect the most commonly used endoscopes, including duodenoscopes, according to the company. It uses a “unique pass-through design that supports one-way workflow to ensure
Drugs
FDA says a draft guidance, Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products—Quality Considerations, is available. A 4/19 Federal Register notice says the guidance’s purpose is to provide recommendations to industry in the development and manufacture of inhalation aerosols. The draft describes points to
Devices
FDA has approved a Sientra PMA supplement allowing commercialization of its Opus-branded breast implant products manufactured by Vesta, a Lubrizol LifeSciences company, at Vesta’s Wisconsin-based manufacturing facility. The devices are being made under “an improved manufacturing process,” according to Sientra. “We will continue our precision-controlled selling
Devices
A coalition of 50 environmental, public health, and children’s rights groups is calling on FDA to “bring its policies FDA in line with the federal government as a whole” and to “publicly advise a phase down of the use of mercury amalgams with the goal of phasing out entirely”
Devices
FDA has released a new Medical Device Safety Action Plan outlining a vision for how the agency can continue to enhance its programs and processes to assure medical device safety. The plan reorganizes what has long been the agency’s most troubled Center. FDA commissioner Scott Gottlieb says the agency