Devices
FDA has cleared a Medo 510(k) for its Medo-Thyroid, an artificial intelligence (AI) device intended to simplify thyroid ultrasound scanning workflow. The device allows users to obtain quick video “sweeps” of each side of the thyroid gland, according to Medo. It then uses AI to automatically review the
Devices
FDA has announced a 5/20 Webinar to share information and answer questions about its medical device Accreditation Scheme for Conformity Assessment (ASCA) Pilot. Under the pilot, the agency grants ASCA recognition to qualified accreditation bodies to accredit testing laboratories to perform premarket testing for medical device companies. The Webinar
Devices
FDA has cleared a Genesis Software Innovations 510(k) for its PreView 3D Shoulder Arthroplasty Planning Software. The device is intended for orthopedic surgeons to develop pre-operative shoulder plans based on CT imaging studies. It assists with surgical planning by showing a representation of the patient’s shoulder anatomy
Biologics
Three U.S. senators have introduced S.1508 (text not yet available) to “harness real-world evidence (RWE) gathered during emergency use authorization to support future approvals for drugs, biologics, and medical devices at FDA.” The bill is sponsored by Sens. Roger Marshall (R-KS), Tina Smith (D-MN), and
Devices
Stryker has petitioned FDA to exempt powered patient transport from premarket notification under section 510(k). The 4/30 petition says: * the devices do not have a significant history of false or misleading claims or risks associated with their inherent characteristics; * characteristics of the devices necessary for their safe and
Devices
FDA is announcing a 6/10 virtual public workshop entitled “Orthopedic Device Postmarket Review.” The workshop is intended to discuss FDA’s postmarket programs and activities related to orthopedic devices, such as recalls, Medical Device Reporting, post-approval and postmarket surveillance studies, inspections, and postmarket approval reporting. “Presenters will discuss
Devices
FDA has cleared a Molli Surgical 510(k) for Molli, a wire-free localization technology for breast cancer surgery. According to Molli, the device helps radiologists mark lesions quickly and accurately, and enables surgeons to locate and remove lesions more efficiently. It comprises an implantable marker, detection wand and visualization
Devices
Pacific Medical Group has recalled the Alaris Infusion Pump Module Model 8100 Front Bezel because components may crack or separate, leading to inaccurate delivery of fluids to patients. The pump is used to deliver fluids such as medications, nutrients, blood, and other therapies into a patient’s body in controlled
Devices
AdvaMedDx says its members develop in vitro diagnostic tests that facilitate evidence-based medicine, improve quality of patient care, enable early detection of disease, and reduce overall healthcare costs. In comments on an FDA guidance, Policy for Evaluating Impact of Viral Mutations on Covid-19 Tests, the association says its
Devices
FDA has granted Lumenis a de novo authorization for its newest intense pulsed light device (IPL) for improving signs of dry eye disease due to meibomian gland dysfunction. The common disorder causes dry, gritty, burning, tired eyes and fluctuating vision, according to the company. The authorization was based on data
Devices
FDA has cleared a Soliton special 510(k) for modifications to its Resonic device and its use for tattoo removal and cellulite treatment. The modifications pertain to an autoloading cartridge and an improved user interface, according to the company. The device uses rapid pulses of acoustic shockwaves for treating cellulite
Devices
Pew Charitable Trusts is calling on HHS to reinstate FDA’s authority to require premarket reviews for laboratory-developed tests. Under the previous administration, an 8/2020 HHS notice (see earlier story) removed premarket reviews for such tests, including tests to detect the virus that causes Covid-19. The major
Devices
The 3/17 FDA/industry MDUFA 5 reauthorization meeting covered these seven topics: FDA presentation of stakeholder feedback from various sources; FDA perspective on MDUFA 4 performance; MDUFA 4 financial information; FDA overview of digital transformation; fully-loaded full-time equivalent cost model methodology; industry perspective on reauthorization, and FDA
Devices
FDA has cleared a Pixee Medical 510(k) for its Knee +, a surgical platform designed to assist orthopedic surgeons by providing real-time positioning of instruments in their field of view. Pixee Medical says the device comprises proprietary software using computer vision and artificial intelligence algorithms that runs on connected
Devices
FDA has granted Medtronic a breakthrough device designation for the Emprint ablation catheter kit, which is intended to be used in conjunction with the Emprint microwave generator and Medtronic lung navigation platform for localized treatment of malignant lesions in the lung. “Using an endoluminal approach, the Emprint ablation catheter kit
Devices
FDA says that after 5/30, it will no longer accept Quality in 510(k) Review files. The agency recommends that companies consider using eSTAR going forward. The Quality in 510(k) Review Program pilot was launched on 9/6/18 to evaluate ways to simplify how manufacturers submit certain
Devices
Becton, Dickinson has submitted a 510(k) for the BD Alaris System that updates the infusion pump to address FDA regulatory issues (see earlier story) raised last year. The device, which the company says is used on about 70% of patients undergoing infusion therapy, has been hampered by a recent
Devices
FDA has approved a Roche PMA for its Ventana MMR RxDx Panel, a companion diagnostic for qualifying patients for treatment with GlaxoSmithKline’s just-approved Jemperli (dostarlimab-gxly) for advanced or recurrent endometrial cancer patients. The qualitative immunohistochemistry test is intended for use in assessing mismatch repair (MMR) proteins in
Devices
FDA has granted a de novo marketing authorization for Neurolutions’ IpsiHand Upper Extremity Rehabilitation System for use in adult patients undergoing stroke rehabilitation to facilitate muscle re-education and for maintaining or increasing range of motion. The brain-computer-interface device is intended to assist in rehabilitatimg stroke patients with
Devices
Cordis has recalled (Class 1) its Precise PRO Rx Carotid System because of the potential for the distal tip to become separated from the lumen wire in specific lots. FDA says about 7,300 devices are affected, and so far seven reported complaints about the defect have been received, including
Devices
FDA has cleared a Soundbite 510(k) for the SoundBite Crossing System — Peripheral with an 0.014” Active Wire. The company says the recanalization tool is designed to help physicians’ placement of conventional guidewires or treatment devices in the intraluminal space beyond chronic total occlusions in patients suffering from heavily
Devices
FDA says that Becton, Dickinson and Company (BD) is recalling 30 specified lots of its ChloraPrep Hi-Lite Orange 26mL applicator (2% w/w chlorhexidine gluconate and 70% v/v isopropyl alcohol) in the U.S. and U.S. territories. An agency announcement says the product is used as an