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Home » Topics » Regulatory

Regulatory
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Man undergoing MRI scan for prostate cancer diagnosis

FDA advances AI-enhanced tech for prostate diagnosis and treatment

Aug. 9, 2022
By Annette Boyle
Recent U.S. FDA actions could transform decades of prostate cancer care. Two companies focused on prostate cancer received good news from the FDA for their artificial intelligence (AI)-driven software. Bot Image Inc. gained FDA clearance for its medical device computer-aided detection and diagnostic tool, Prostatid. The agency also provided FDA investigational device exemption for Avenda Health Inc.’s Focalpoint ablation system that enables more accurate mapping of a patient’s prostate cancer for better surgical results.
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Person standing on Bodyport scale in bathroom

Bodyport claims FDA clearance for cardiac weight scale

Aug. 9, 2022
By Catherine Longworth
The U.S. FDA granted digital therapeutics company Bodyport Inc. 510(k) clearance for its heart monitoring weight scale. The digital solution includes sensors and algorithms that measure hemodynamic biomarkers to assess heart function and fluid status when patients take their daily weight. San Francisco-based Bodyport told BioWorld the platform is for heart failure (HF) patients in the U.S.
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Nothing misleading here, US First Circuit tells Karyopharm investors

Aug. 9, 2022
By Mari Serebrov
An investor’s wish to know more about the total landscape of a drug candidate is not enough, on its own, to make a company’s disclosures about the drug and its development materially misleading. So said the U.S. Court of Appeals for the First Circuit in affirming the dismissal of a shareholder suit against Karyopharm Therapeutics Inc. and its executive officers.
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FDA approves Daiichi Sankyo/Astrazeneca’s Enhertu for HER2 low metastatic breast cancer

Aug. 9, 2022
By Tamra Sami
The U.S. FDA has approved Daiichi Sankyo Co. Ltd. and Astrazeneca plc’s Enhertu (fam-trastuzumab deruxtecan) as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer.
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Regulatory actions for Aug. 9, 2022

Aug. 9, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avenda, Bodyport, Bot Image, Cerevasc, Imspex Diagnostics, Medalliance, Neuroone.
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Regulatory actions for Aug. 9, 2022

Aug. 9, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Bayer, Daiichi, Immvira, Myovant, Orion, Scisparc, Tracon.
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SEC reins in Suralign for shipping orders ahead of schedule in violation of Sarbanes-Oxley

Aug. 8, 2022
By Mark McCarty
When medical device manufacturers think of U.S. federal government enforcement, the Sarbanes-Oxley Act (SOX) of 2002 might not be the first element of the statute to come to mind. However, the Securities and Exchange Commission (SEC) used SOX to snare Suralign Holdings Inc. for pushing orders to customers ahead of schedule to draw the related revenue forward, an allegation that led to restitutions and penalties amounting to nearly $3 million.
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Breast implants

FDA reports 59 deaths across the globe due to lymphoma associated with breast implants

Aug. 8, 2022
By Mark McCarty
The U.S. FDA has updated its data on the number of fatalities across globe associated with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), which has now reach 59 fatalities. That number is up from 33 reported in July 2019 but is also a number the agency continues to assert may be a significant undercount.
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Regulatory actions for Aug. 8, 2022

Aug. 8, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Microport Navibot.
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US Rx price negotiations a step away from law

Aug. 8, 2022
By Mari Serebrov
Within a few weeks, government price negotiations for some prescription drugs, as well as limits on annual price increases, could be the law of the land in the U.S. With the Senate passing a slimmed-down version of H.R. 5376 through reconciliation Aug. 7, the House is expected to make a brief return Friday from its August recess to vote on the changes and conference the differences between its bill and the Senate version. Then it’s on to the president’s desk for the signature that will enact the package of health care, tax and climate provisions.
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