FDA – Medical Alley Association

FDA

Sonic Beam Therapy Pioneers HistoSonics Awarded Payment Rate For Novel Histotripsy Procedure in CMS 2022 Final Rule

Medical Alley Association startup member HistoSonics’ novel histotripsy procedure has been awarded procedural payment rate, taking effect on January 1st, 2022 Medical Alley, MN – The Centers for Medicare and Medicaid Services, as part of the 2022 Hospital Outpatient Prospective Payment System (OPPS) final rule, have set a facility procedure payment rate for histotripsy of the […]

Newly Published physIQ and UI Health Study on the Efficacy of Novel COVID-19 Decompensation Index

NIH-funded DeCODe clinical study evaluates FDA-cleared AI analytics platform (pinpointIQTM) and a wearable biosensor to remotely monitor patients with COVID-19 First-in-Kind COVID-19 Decompensation Index (CDI) identifies early signs of worsening health with a lower false alarm rate compared to standard-of-care modalities Findings suggests the potential for wearable sensor-based analytics to detect exacerbation of infectious disease […]

UserWise Facilitates FDA Emergency Use Authorization for Detect™ Over-the-Counter COVID-19 Test

UserWise, Inc., a San Jose, California-based Human Factors consultancy for medical products, conducted an expedited 100-participant FDA-compliant human factors study within a 3-week span to facilitate an Emergency Use Authorization (EUA) for the Detect™ COVID-19 Test for over-the-counter home use. San Jose, CA, November 08, 2021 –(PR.com)– UserWise, Inc., a San Jose, California-based Human Factors consultancy […]

Cardialen Receives FDA Approval to Conduct Clinical Trial of Low-Energy Atrial Fibrillation Treatment

U.S. Food and Drug Administration approval of a clinical trial of Cardialen’s low-energy defibrillation and cardioversion therapy expands the number of leading clinical institutions evaluating its promising MultiPulse™ Therapy. Minneapolis, Nov. 17, 2021 – Cardialen, Inc., has received approval from the U.S. Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) to begin a […]

Pear Prescription Digital Therapeutics (PDT) Digest

Pear Therapeutics Launches Pear Prescription Digital Therapeutics Digest, Provides Roadmap for Payer Coverage Considerations Pear Therapeutics is the leader in developing and commercializing prescription digital therapeutics (PDTs) to treat serious disease, with three FDA-authorized PDTs Inaugural edition of the Digest explores employer and payer stakeholder knowledge of PDTs as well as current considerations and perceptions […]

FDA Clearance of an Expanded Indication for the SPRINT® PNS System Now Enables Treatment in Areas of the Head, Neck, and Torso

CLEVELAND, Ohio (Oct. 19, 2021) – SPR Therapeutics® has obtained clearance from the U.S. Food and Drug Administration (FDA) of a broader indication for use for its SPRINT Peripheral Nerve Stimulation (PNS) System. Prior clearance limited use of the SPRINT PNS System to the back and extremities, but the new indication allows the device to be used […]

Spark Biomedical and Velentium Named ‘Most Innovative’ in Houston

MedTech companies honored at the Houston Business Journal’s third-annual Innovation Awards for life-changing neurostimulation device HOUSTON, TX – October 13, 2021 – Spark Biomedical (Spark) – a Texas-based medical device company and developer of the first drug-free, personalized, wearable solution for opioid withdrawal relief – and Velentium – a professional engineering firm that specializes in the design and manufacturing […]

FDA signs off on change to contraindications for GE’s Optison agent

October 5, 2021 — The U.S. Food and Drug Administration (FDA) has approved the removal of hypersensitivity to blood and blood products from the listed contraindications for GE Healthcare‘s Optison echocardiography contrast agent. As a result, Optison’s prescribing information now only includes a contraindication in patients with known or suspected hypersensitivity to perflutren or albumin. GE said […]

RQM+ MDR Clinical Evaluation Roadmap: An Interview with Jai Kutty

The introduction of MDR caused a major transformation in the medical device industry. Manufacturers continue to grapple with all elements of compliance, but clinical evaluation presents unique challenges. RQM+ is committed to helping clients navigate these challenges with former notified body leaders who understand what reviewers are looking for when evaluating clinical evidence. Introduction to Dr. […]

The Value of Real World Evidence and Secondary Data in MedTech – Part 1 in a Series

Regulators’ Growing Adoption of Real World Evidence Brinda Sriskantha, PhD, Director, Real World Solutions, IQVIA MedTech and Michelle Bulliard, Vice President, Real World Solutions, IQVIA MedTech Regulators have been steadily increasing their use of real world evidence (RWE) to support decision-making. Simultaneously, access to real world data (RWD) continues to increase, and there’s growing clarity […]

Keep your finger on the pulse of Medical Alley from anywhere with the ALLEY NEWSLETTER