TOBY Secures US FDA Breakthrough Device Designation for Urine-Based Multi-Cancer Test

Shots: The US FDA has granted Breakthrough Device Designation to the urine-based Multi-Cancer Early Detection (MCED) test The non-invasive platform analyzes volatile organic compounds (VOCs) using spectroscopy & machine learning to detect multiple cancers from a single urine sample The test provides an alternative to blood-based screening, supporting scalable population screening, while the designation enables…

ByRidhi RastogiApril 15, 2026

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American Industrial Partners to Acquire Avanos Medical for ~$1.272B

Shots: Avanos Medical has entered into a definitive agreement to be acquired by affiliates of American Industrial Partners in an all-cash transaction valued at ~$1.272B enterprise value As per the deal, Avanos Medical shareholders will receive $25/share in cash, reflecting a ~72.1% premium to the Company's closing stock price on Apr 13, 2026; closing is…

ByRidhi RastogiApril 14, 2026

NEWS

Protaryx Medical Secures FDA Clearance for its Transseptal Access Device

Shots: The US FDA has granted 510(k) clearance to the Transseptal Puncture Device to advance minimally invasive access for left-heart procedures, with plans to begin US commercialization The Device is a next-gen system enabling zero-exchange access to the left heart, integrating RF guidewire tech with standard electrosurgical generators & an echogenic, extendable atraumatic probe to…

ByRidhi RastogiApril 14, 2026

NEWS

Miracell Reports US FDA 510(k) Clearance for SMART M-CELL PRP and Bone Marrow Concentration Systems

Shots: The US FDA has granted 510(k) clearance to Miracell’s SMART M-CELL PRP Concentration System and Bone Marrow Concentration System, including associated blood and bone marrow kits Clearance was based on substantial equivalence to SmartPReP, with the system demonstrating high cell viability, efficient growth factor extraction, and integrated performance across centrifuge and kit components SMART…

ByPrince GiriApril 13, 2026

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Waters Expands Cervical Cancer Screening Access with at-Home HPV Test Approval

Shots: The US FDA has granted clearance to the Onclarity HPV Self-Collection Kit & approved the BD Onclarity HPV Assay for at-home use, expanding access to cervical cancer screening The kit is tested with the BD Onclarity HPV Assay, detecting all high-risk HPV genotypes with individual & pooled results, & processed on the automated BD…

ByRidhi RastogiApril 9, 2026

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Anumana Secures the US FDA 510(k) Clearance for its ECG-AI Algorithm to Detect Risk of Cardiac Amyloidosis Early

Shots: The US FDA has granted clearance to ECG-AI algorithm, a software-as-a-medical-device designed for cardiac amyloidosis (CA), cleared for use with standard 12-lead ECGs ECG-AI algorithm analyzes ECG waveforms to detect CA-related patterns not visible to clinicians, integrating into existing workflows using routine ECGs without additional testing to help identify at-risk pts & guide next…

ByRidhi RastogiApril 9, 2026

NEWS

Endospan’s Nexus System Receives the US FDA Approval to Treat Aortic Arch Disease

Shots: The US FDA has approved the Nexus Aortic Arch Stent Graft for the treatment of aortic arch disease Approval was supported by the 1yr. results from the TRIOMPHE IDE trial assessing Nexus in aortic arch disease, incl. chronic aortic dissections, in pts at high risk for open surgical repair, which showed safe & effective treatment in…

ByRidhi RastogiApril 8, 2026

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Organogenesis Reports Trial Results on PuraPly AM for Wound Healing in Diabetic Foot Ulcers

Shots: Organogenesis has reported the trial completion of PuraPly AM, assessing it in combination with SoC vs SOC alone for the management of non-healing diabetic foot ulcers (DFUs) The 170-patient trial achieved its 1EP, showing significant wound closure at 12wks., with the company planning to publish the study results soon in a journal PuraPly AM…

ByRidhi RastogiApril 7, 2026

NEWS

Allevion Secures FDA Clearance for Vantage Spinal Decompression System

Shots: The US FDA has granted 510K Clearance to Vantage, a fully disposable, sterile system designed for minimally invasive lumbar decompression procedures Vantage features a structured “locate, dilate, decompress” workflow with integrated illumination for direct visualization, enabling precise, depth-controlled bone resection while improving procedural consistency & safety The single-use system eliminates the need for reusable…

ByRidhi RastogiApril 6, 2026

NEWS

restor3d Reports Full Commercial Launch of Aeros Modular Stem System for Total Ankle Replacement

Shots: restor3d has reported the full commercial availability of the Aeros Modular Stem System, a next-generation total ankle replacement platform designed to enhance implant stability, preserve bone, & improve surgical efficiency Launched with a limited market release, the system enables flexible implant configurations and introduces a modular stem tibial implant that can be placed via…

ByRidhi RastogiApril 3, 2026

TOBY Secures US FDA Breakthrough Device Designation for Urine-Based Multi-Cancer Test

American Industrial Partners to Acquire Avanos Medical for ~$1.272B

Protaryx Medical Secures FDA Clearance for its Transseptal Access Device

Miracell Reports US FDA 510(k) Clearance for SMART M-CELL PRP and Bone Marrow Concentration Systems

Waters Expands Cervical Cancer Screening Access with at-Home HPV Test Approval

Anumana Secures the US FDA 510(k) Clearance for its ECG-AI Algorithm to Detect Risk of Cardiac Amyloidosis Early

Endospan’s Nexus System Receives the US FDA Approval to Treat Aortic Arch Disease

Organogenesis Reports Trial Results on PuraPly AM for Wound Healing in Diabetic Foot Ulcers

Allevion Secures FDA Clearance for Vantage Spinal Decompression System

restor3d Reports Full Commercial Launch of Aeros Modular Stem System for Total Ankle Replacement

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