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FDA Breakthrough Therapy and RMAT: Strategic Decisions That Can Accelerate Oncology Development

Explore how FDA Breakthrough Therapy and RMAT designations can create opportunities for oncology programs when backed by the right development strategy.

United Therapeutics nabs FDA approval for donor-lung assessment device

United Therapeutics has been given a premarket approval from the FDA for its LungFX device.

CMS Announces RAPID Coverage Pathway to Speed Medicare Coverage of New Medical Devices

The Gap Between FDA Authorization and Medicare Coverage In April 2026, the Centers for Medicare & Medicaid Services (“CMS”) and the U.S. Food and Drug Administration (“FDA”) an...

HepQuant nabs FDA premarket approval for liver diagnostic test

The FDA has granted premarket approval to HepQuant’s liver diagnostic test for the treatment of adults with Child-Pugh Class A compensated cirrhosis, according to a company press r...

This Ear-Based Device Could Save Patients from Brain Bleed Complications

Aurenar’s V-Link, a non-invasive nerve stimulation device for preventing brain hemorrhage complications, just won FDA breakthrough device designation after early trials showed it c...

<![CDATA[FDA’s New Pilot Program and Real-Time Review of Clinical Data]]>

SpinaFX Medical receives FDA Investigational Device Exemption (IDE) for Triojection®, its Breakthrough, Minimally-Invasi...

The prospective, randomized, multicenter trial will compare intradiscal ozone/oxygen injection plus nerve root block to nerve root block…

FDA Clears First Neurostimulation Device for PTSD

Neurovalens’ Modius Spero has become the first FDA-approved neuromodulation device for treating PTSD symptoms. Veterans are set to gain access through the VA this summer. The post...

<![CDATA[FDA Expands Enhertu in Early HER2-Positive Breast Cancer]]>

<![CDATA[FDA Sends CRL to Cingulate for CTx-1301]]>

<![CDATA[FDA Pilot Targets Faster Early-Stage Drug Trial Starts]]>

FDA Issues Draft Guidance to Help Accelerate Cell and Gene Therapies for Patients

The U.S. Food and Drug Administration (FDA) today issued draft guidance to help developers bring promising gene therapies to patients more efficiently by making greater use of ex...

Guardant Health nabs FDA test approval to find patients for Boehringer’s new cancer drug

Boehringer Ingelheim’s Hernexeos has nabbed a companion diagnostic from Guardant Health after the FDA cleared its liquid biopsy test, Guardant360 CDx.

<![CDATA[FDA Approves Datroway for Patients with Metastatic Triple-Negative Breast Cancer Who Are Not PD-1/PD-L1 Inhi...

Penumbra’s THUNDERBOLT Receives FDA Clearance – Bringing Computer Assisted Vacuum Thrombectomy Technology to Stroke

THUNDERBOLT is the first CAVT platform to deliver modulated aspiration for acute ischemic stroke — enabling faster, more…

IHealthScreen nabs FDA nod for AI-backed dx to spot mild diabetic retinopathy

IHealthScreen hauled in FDA 510(k) clearance for its AI-powered diagnostic that detects mild diabetic retinopathy in diabetic adults who have gone undiagnosed with the condition.

At first public hearing for FDA’s CNPV program, industry support meets ‘deep concern’ from experts

On Thursday, the public had the first chance to air their grievances about the FDA’s controversial Commissioner’s National Priority Voucher (CNPV) pilot program, the flagship initi...

FDA issues early alert for J&J’s Abiomed catheter introducer over manufacturing issues, bleeding risk

The FDA has sent out an early alert to J&J’s Abiomed unit and its manufacturing partner, Oscor, for their catheter introducer kits that are used with Impella heart pumps amid m...

FDA drops blood pressure device enforcement against Whoop

The FDA has sent an End of Enforcement notice to consumer wearable device company Whoop, putting a formal end to the agency’s investigation into its blood pressure tech use.

SpinaFX Medical receives FDA Investigational Device Exemption (IDE) for Triojection®, its Breakthrough, Minimally-Invasi...

SpinaFX Medical's prospective, randomized, multicenter trial will compare intradiscal ozone/oxygen injection plus nerve root block to nerve root block alone in 300 patients in up t...

FDA Grants De Novo Clearance to Burn Wound Assessment System

The AI-based imaging system is designed to help clinicians assess burn wound healing potential and identify wounds that may require intervention.

Neurovalens gets US FDA approval for PTSD treatment device

Other devices developed by the Northern Irish company for the treatment of insomnia, anxiety and weight management have previously received various levels of FDA approval. Read mo...

Solenic MedicalВ® Receives FDA IDE Approval to Initiate Pivotal Trial of SOLA-2в„ў for Periprosthetic Joint Infections

Solenic Medical today announced that the FDA has approved the its IDE application, authorizing the launch of a pivotal clinical trial for its SOLA-2в„ў Alternating Magnetic Field S...

<![CDATA[Pharmaceutical Executive Daily: FDA Pilot Targets Faster Early-Stage Drug Trial Starts]]>