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News You Need to Know Today
FDA highlights new Class I recall | Startup co-founded by cardiologist emerges from stealth with big plans | IVL data
Wednesday, November 5, 2025
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Today's News and Trends

FDA highlights new Class I recall for Dexcom CGM app

Dexcom recalled its G6 smartphone app after a software error was causing it to stop working with no warning. This is a Class I recall, which means failing to follow the company's instructions could result in a serious adverse event.

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Dexcom is recalling a specific version of the Android smartphone app associated with its G6 Continuous Glucose Monitoring (CGM) System.
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FDA highlights new Class I recall for Dexcom CGM app

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Dexcom is recalling a specific version of the Android smartphone app associated with its G6 Continuous Glucose Monitoring (CGM) System.
Dexcom recalled its G6 smartphone app after a software error was causing it to stop working with no warning. This is a Class I recall, which means failing to follow the company's instructions could result in a serious adverse event.
READ MORE >

Medtech startup co-founded by cardiologist seeks FDA clearance for new-look perfusion device

Tulyp Medical, a French medtech startup, has emerged from stealth focused on securing FDA clearance for a patented perfusion device.

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startup business healthcare medtech heart
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Medtech startup co-founded by cardiologist seeks FDA clearance for new-look perfusion device

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startup business healthcare medtech heart
Tulyp Medical, a French medtech startup, has emerged from stealth focused on securing FDA clearance for a patented perfusion device.
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Shockwave Medical’s IVL catheter for peripheral lesions linked to positive 1-year data

The new findings, presented during a late-breaking presentation, focused on 110 PAD patients treated with Shockwave Medical's Javelin Peripheral IVL Catheter.

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Shockwave Medical Javelin Peripheral IVL Catheter
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Shockwave Medical’s IVL catheter for peripheral lesions linked to positive 1-year data

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Shockwave Medical Javelin Peripheral IVL Catheter
The new findings, presented during a late-breaking presentation, focused on 110 PAD patients treated with Shockwave Medical's Javelin Peripheral IVL Catheter.
READ MORE >

Featured Articles

Pulmonary embolism thrombectomy use increases by more than 700%

Medicare claims submitted between 2017 and 2022 showed a 712% increase in thrombectomy for pulmonary embolism (PE) and a 137% increase in thrombectomy for deep vein thrombosis (DVT).

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The Penumbra thrombectomy pulmonary embolism clots extraction catheter displayed at TCT 2025. Photo by Dave Fornell
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Pulmonary embolism thrombectomy use increases by more than 700%

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The Penumbra thrombectomy pulmonary embolism clots extraction catheter displayed at TCT 2025. Photo by Dave Fornell
Medicare claims submitted between 2017 and 2022 showed a 712% increase in thrombectomy for pulmonary embolism (PE) and a 137% increase in thrombectomy for deep vein thrombosis (DVT).
READ MORE >

Medicare Physician Fee Schedule cuts cardiologist pay because CMS says doctors should be more efficient

The new, negative 2.5% efficiency adjustment will be applied to the vast majority of Medicare payments for physician services. It was opposed by cardiology and most other medical societies. 

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Medicare physician fee schedule final rule 2026.
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Medicare Physician Fee Schedule cuts cardiologist pay because CMS says doctors should be more efficient

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Medicare physician fee schedule final rule 2026.
The new, negative 2.5% efficiency adjustment will be applied to the vast majority of Medicare payments for physician services. It was opposed by cardiology and most other medical societies. 
READ MORE >

Cardiologist Peter Soukas becomes chief medical officer of carotid stent company

The company said the move will help it prepare for what is expected to be a rapid expansion of carotid stenting.

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Well-known cardiologist Peter A. Soukas, MD, FACC, FSCAI, FSVM, FACP, has become chief medical officer of carotid stent maker InspireMD Inc.
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Cardiologist Peter Soukas becomes chief medical officer of carotid stent company

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Well-known cardiologist Peter A. Soukas, MD, FACC, FSCAI, FSVM, FACP, has become chief medical officer of carotid stent maker InspireMD Inc.
The company said the move will help it prepare for what is expected to be a rapid expansion of carotid stenting.
READ MORE >

In Case You Missed It

Judge files lawsuit over husband’s death—alleges heart symptoms were mismanaged

The patient reported chest pain multiple times and had a family history of heart disease. According to the lawsuit, however, he was never referred to a cardiologist. 

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An Illinois appellate judge upheld a pervious trial victory that cleared and central Illinois cardiologist Amit Dande, MD, and Prairie Cardiovascular Consults LLP of alleged misdiagnosis of the severity of a patient's heart condition that led to his death prior to a schedule percutaneous coronary intervention (PCI).
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Judge files lawsuit over husband’s death—alleges heart symptoms were mismanaged

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An Illinois appellate judge upheld a pervious trial victory that cleared and central Illinois cardiologist Amit Dande, MD, and Prairie Cardiovascular Consults LLP of alleged misdiagnosis of the severity of a patient's heart condition that led to his death prior to a schedule percutaneous coronary intervention (PCI).
The patient reported chest pain multiple times and had a family history of heart disease. According to the lawsuit, however, he was never referred to a cardiologist. 
READ MORE >

FDA confirms Class I recall for Johnson & Johnson devices due to durability concerns

The issue, first reported in September, was linked to five patient injuries. Devices not being actively used should be returned to Johnson & Johnson MedTech for updates.

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Johnson & Johnson MedTech Automated Impella Controller
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FDA confirms Class I recall for Johnson & Johnson devices due to durability concerns

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Johnson & Johnson MedTech Automated Impella Controller
The issue, first reported in September, was linked to five patient injuries. Devices not being actively used should be returned to Johnson & Johnson MedTech for updates.
READ MORE >

Cardiology leader, a ’40 under 40’ winner, arrested for leaving baby on beach

Both parents were arrested for neglect and then released the next day after posting a $1,000 bond. The child was unharmed.

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handcuffs arrested arrest jail
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Cardiology leader, a ’40 under 40’ winner, arrested for leaving baby on beach

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handcuffs arrested arrest jail
Both parents were arrested for neglect and then released the next day after posting a $1,000 bond. The child was unharmed.
READ MORE >

In Other News

Report: CMS sent states lists of names for impromptu Medicaid eligibility check

President Donald Trump’s administration wants states to check to see if hundreds of thousands of residents are enrolled in Medicaid illegally. CMS provided a specific list of people it suspects are undocumented.

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Report: CMS sent states lists of names for impromptu Medicaid eligibility check

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President Donald Trump’s administration wants states to check to see if hundreds of thousands of residents are enrolled in Medicaid illegally. CMS provided a specific list of people it suspects are undocumented.
READ MORE >

FDA grants De Novo marketing authorization for at-home prenatal ultrasound

Women's health experts are calling the approval a "long-awaited leap forward" for obstetrical care.

READ MORE >
pregnant-g15799b22a_1920_copy.jpg
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FDA grants De Novo marketing authorization for at-home prenatal ultrasound

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pregnant-g15799b22a_1920_copy.jpg
Women's health experts are calling the approval a "long-awaited leap forward" for obstetrical care.
READ MORE >

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