Elidah Inc. expanded its line of U.S. FDA-cleared, over-the-counter devices to reduce or eliminate urinary incontinence in women with the launch of Elitone Urge for urge incontinence. The device is a muscle stimulator that can be worn under clothes as the user goes about her day and rebuilds muscle tone.
In its first markup of the 118th Congress May 2, the Senate Health, Education, Labor and Pensions (HELP) Committee, under the new leadership of Sen. Bernie Sanders (I-Vt.), devolved into a brief mutiny of sorts as the committee members started to take up four bipartisan bills aimed at taming prescription drug prices.
The new bedside monitor Carescape Canvas will work in tandem with the Carescape One acquisition device also developed by GE Healthcare Technologies Inc. and cleared for sale in the U.S. in 2019. Together, they scale up or down monitoring capabilities based on the acuity of each individual patient and according to the company provide sufficient flexibility to monitor patients across different health care settings within a hospital.
The U.S. Centers for Medicare and Medicaid Services’ years-long musing over a streamlined coverage policy specifically for breakthrough medical devices is now taking a toll on breakthrough medications that could provide a cure or arrest the progression of debilitating diseases.
Dexcom Inc. posted a 19% increase in first quarter revenues compared to 2022 boosted by a stunning 27% organic growth in sales outside the U.S. With clearance of the G7 device in hand, another record set in new patient starts and coverage of continuous glucose monitoring (CGM) systems by CMS effective this month, the year is shaping up to be quite rosy for the diabetes device company.
Ultromics Ltd. has been granted a U.S. FDA breakthrough device designation for its artificial intelligence (AI)-enhanced platform to aid early diagnosis of cardiac amyloidosis. Echogo Amyloidosis uses AI to analyze echocardiograms and detect the presence of cardiac amyloidosis, using a single commonly acquired ultrasound view of the heart. The platform was developed with the support of Janssen Biotech Inc., part of the Janssen Pharmaceutical Companies, a unit of Johnson & Johnson.
The legislative pile-on continues as the U.S. Congress considers more ways to take down health care costs while defending innovation. The House Energy and Commerce Subcommittee on Health met April 26 to consider 17 draft discussion bills offered as bipartisan solutions to lower costs by increasing transparency and competition across the health care playing field.
Dublin-based Medtronic plc, and the U.S. FDA have wrapped up their discussion of the December 2021 warning letter for the company’s manufacture of continuous glucose monitors, clearing a hurdle that was critical in restoring the company’s footprint in the U.S. market. Left unanswered from the resolution of the warning letter is whether the FDA believes that device makers need to track the number of devices in distribution vs. those in actual use in order to properly calculate the risk of device failure based on postmarket surveillance.
U.S. Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure made her first appearance April 26 before the House Energy and Commerce’s Subcommittee on Health, ostensibly to discuss legislative solutions to increase transparency and competition in health care. But member after member, regardless of political party, demanded answers about why CMS continues to severely restrict access to Eisai Co. Ltd.’s Alzheimer’s drug, Leqembi (lecanemab), especially since another government agency is covering it for all veterans that meet the labeling requirements.
The U.S. Supreme Court has declined to hear a case that tests the notion that artificial intelligence (AI) can be an inventor, a development that may be nothing more than the beginning of the AI-as-inventor story under U.S. law. The Patent and Trademark Office’s (PTO) April 25 webinar on the subject included some remarks that AI could be used to produce a tsunami of potentially duplicative patent applications, but the event demonstrated that there is almost no at-large support for AI-as-inventor, suggesting that the status quo will stand for the time being.
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