STAT

NOVEMBER 17, 2023

The Food and Drug Administration has approved a Medtronic device to lower blood pressure, the company announced Friday evening. The decision comes after an advisory panel narrowly voted against the device in August. ” Continue to STAT+ to read the full story…

FDA 135

FDA 135

European Pharmaceutical Review

JANUARY 29, 2024

In the published in 2023, the process and requirements for toxicological risk assessment of medical device constituents is outlined. The paper discussed the detection of volatile extractables released during the clinical use of medical devices.

Compounding 88

Compounding FDA 88

pharmaphorum

SEPTEMBER 29, 2022

In Part 1 of this series, general wellness devices and mobile medical applications (MMAs) will be considered. Part 2 of this series will be devoted to clinical decision support (CDS) software. Food and Drug Administration (FDA) regulation as a medical device. not a medical device, ii.

FDA 104

FDA Documentation 104

Fierce Healthcare

OCTOBER 10, 2023

In May, Microsoft rolled out Microsoft Fabric, an end-to-end, unified analytics p | Microsoft unveiled industry-specific healthcare solutions in Fabric that will enable organizations to combine data from previously siloed sources and integrate structured and unstructured clinical information along with imaging and medical device data.

129

129

The FDA Law Blog

MARCH 19, 2024

The draft guidance applies to medical devices that heat or cool tissue as an intended or unintended consequence of device use. To evaluate the thermal effects of a device, the draft guidance recommends that bench testing precede evaluation of thermal effects. By Adrienne R.

FDA 59

FDA 59

STAT

AUGUST 22, 2023

The committee will evaluate data from two companies vying for market approval: ReCor Medical, a startup owned by Japanese company Otsuka Medical Devices, and device giant Medtronic, both of which have made surgical systems to treat hypertension. Neither study presented serious safety concerns.

FDA 97

FDA 97

The FDA Law Blog

OCTOBER 18, 2023

Lenz, Principal Medical Device Regulation Expert — Although it seems not widely known outside of the medical device industry, FDA can require sponsors to include clinical data as part of a 510(k) submission. By Adrienne R.

FDA 64

FDA Medical Records 64

STAT

FEBRUARY 15, 2024

Remote patient monitoring coding reforms tabled again Earlier this month, an  American Medical Association -anointed panel was set to consider proposed changes that would have simplified and broadened applicability of billing codes governing wearables and other devices doctors can use to monitor patients outside the clinic.

114

114

The FDA Law Blog

OCTOBER 16, 2023

Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products. The third article—“Your Medical Devices are Getting Smarter. The first article—“Is the Eye the Window to Alzheimer’s?” demographic bias of data fed to algorithms).

Documentation 119

Documentation FDA 119

STAT

OCTOBER 25, 2023

As one of the largest and oldest medical device companies in the world, Medtronic has a foot in almost every clinical area. The device maker with a market valuation of nearly $100 billion sells pacemakers, spinal cord stimulators, stents, monitors. Name a device, and they probably make it.

97

97

STAT

NOVEMBER 21, 2023

If Paul Grand weren’t the CEO of MedTech Innovator, the largest medical device accelerator in the world, he might have been a keychain salesman. He started it to empower entrepreneurs discouraged by a funding dry spell precipitated by the 2009 financial crisis, and to fill the void of a medical device-specific accelerator.

130

130

Pharmaceutical Technology

APRIL 26, 2023

But experts say the complete integration of these devices and platforms into the healthcare system remains to be seen. Dr. Amy Chan, senior clinical research fellow at the School of Pharmacy, University of Auckland, says digital inhalers have existed for almost 30 years.

Medication Delivery 115

Medication Delivery Communication 115

The FDA Law Blog

NOVEMBER 29, 2023

FDA announced that FDA, Health Canada, and MHRA are jointly publishing guiding principles for PCCPs for AI/ML devices to help stakeholders when developing solutions for these countries. Risk-based This guiding principle ensures risk management principles are used to evaluate the individual and cumulative changes over the life of the device.

FDA 115

FDA Labelling Communication 115

pharmaphorum

SEPTEMBER 28, 2022

The US FDA’s Center for Devices and Radiological Health (CDRH) dropped a bevy of new digital health guidances and reports today and yesterday, providing some long-awaited clarity and peeks into the agency’s future plans. . The Pre-Cert pilot report.

FDA 135

FDA Documentation 135

STAT

FEBRUARY 23, 2023

In September, the FDA announced its intentions to regulate many of these AI-powered clinical decision support (CDS) tools as devices — which regulators say has always been their plan and within their purview. But the industry says it was blindsided by the move. Continue to STAT+ to read the full story…

FDA 100

FDA Patient Care 100

STAT

JUNE 6, 2023

CHICAGO — A medical device made by Novocure that creates electric fields in the lungs via wearable skin patches extended the survival of patients with lung cancer in a clinical trial, researchers reported Tuesday.

Chemotherapy 101

Chemotherapy Immunization 101

Pharmaceutical Technology

JANUARY 29, 2024

The upcoming OCT West Coast 2024 conference will feature experts talking about emerging techologies, clinical trial operations for pharma and medical devices, and patient participation in studies.

52

52

The FDA Law Blog

FEBRUARY 7, 2023

Lenz, Principal Medical Device Regulation Expert — For medical device start-up companies, understanding and successfully navigating applicable FDA regulations and requirements is an important part of the path to market. Part 814), and for conducting clinical trials (21 C.F.R. By Adrienne R.

Documentation 98

Documentation FDA Labelling 98

The FDA Law Blog

MARCH 11, 2024

Lenz, Principal Medical Device Regulation Expert & Allyson B. Mullen — On February 20, 2024, FDA issued a letter to the medical device industry ( link ) warning medical device firms of recent FDA concerns related to fraudulent and unreliable laboratory testing data in premarket submissions.

FDA 64

FDA Communication 64

Pharmaceutical Technology

DECEMBER 27, 2022

Along the way, mergers and acquisitions continued to happen, new drugs and devices got approved, and innovations in the clinical trial industry were introduced. Still, the country’s clinical trials sector remains insular. Tracking the news. Tracking drug development. Tracking the diversity push.

Vaccines 122

Vaccines 122

STAT

JULY 31, 2023

Flow Neuroscience, a small Swedish company treating depression with brain-stimulating headsets, released early data on Monday showing that its device relieved depressive symptoms in clinical trials.  Flow already sells its devices over-the-counter in Europe, where it received regulatory approval in 2019.

FDA 98

FDA 98

STAT

NOVEMBER 11, 2023

PHILADELPHIA — A new study, and the bold doctor who led it, could result in big questions about how researchers study medical devices and surgical treatments and, eventually, what procedures patients undergo. Continue to STAT+ to read the full story…

143

143

STAT

NOVEMBER 8, 2023

The Food and Drug Administration approved a surgical system used to reduce blood pressure from Recor Medical, the company announced Wednesday. The therapy, a simple procedure to reduce the blood pressure of millions of Americans , was once seen as a boon for cardiologists and device makers.

FDA 112

FDA 112

Roots Analysis

FEBRUARY 20, 2024

This clinical condition impacts individuals of all ages and backgrounds, but it often goes undiagnosed or overlooked, affecting the individuals’ overall quality of life and well-being. In this article, we have highlighted details on Sleep Apnea Devices Market.

Compounding 40

Compounding 40

pharmaphorum

SEPTEMBER 27, 2022

Five wearable devices that monitor patients with Parkinson’s disease as they go about their lives have been given a provisional recommendation from NICE, making them available via the NHS while additional data is collected.

105

105

European Pharmaceutical Review

SEPTEMBER 27, 2022

The guidance , called ‘Ethical Considerations for Clinical Investigations of Medical Products Involving Children’, offers advice to institutional review boards (IRBs) and the industry at large when deciding whether to include children in studies about drugs, biological products and medical devices.

FDA 94

FDA Labelling 94

pharmaphorum

JUNE 10, 2022

A lot of innovators are in the same boat as, despite laudable efforts by the agency, there’s still a lot of misinformation and a lack of clarity around how digital health devices, especially software as a medical device, are regulated. Drugs and devices are two completely different animals.

FDA 133

FDA Documentation 133

STAT

MARCH 30, 2023

The Food and Drug Administration on Thursday released a new plan allowing developers of medical devices that rely on artificial intelligence to automatically update products already being used in the clinic.

Documentation 104

Documentation FDA 104

Roots Analysis

AUGUST 7, 2023

Over the past 50 years, the medical device industry has seen several notable developments. In fact, the use of biomedical devices, such as medical implants, surgical instruments, and prostheses has increased substantially over the time. Every year, millions of individuals undergo surgeries and implantations.

Adverse Reactions 52

Adverse Reactions 52

The FDA Law Blog

AUGUST 28, 2023

Lenz, Principal Medical Device Regulation Expert — Following up on our first post discussing Digital Health Technologies (DHTs) ( here ), this post will focus on development and qualification of DHTs for use in clinical trials for drug development. By Adrienne R.

FDA 59

FDA 59

STAT

APRIL 6, 2023

The landscape of obesity treatment is quickly changing — and with its acquisition this week of Apollo Endosurgery, medical device maker Boston Scientific is again shaking up the space. “We want to get our experience using a technology that has clinical data to support its use.

91

91

Roots Analysis

FEBRUARY 6, 2023

Medical Device Coatings – From Supplementary Protection Constituents to Necessary Tools for Various Functions Over the past 50 years, the medical device industry has seen several notable developments. Further, since 2020, the Food and Drug Administration (FDA) has approved 125 medical devices.

FDA 52

FDA 52

Roots Analysis

FEBRUARY 26, 2024

Given the robust pipeline of biologics, which include monoclonal antibodies, vaccines and other protein-based therapeutic products, subcutaneous medications are being investigated for various clinical candidates across different phases of development.

Medication Delivery 52

Medication Delivery Pharmaceutical Companies Pharmaceutical Companies Vaccines 52

The Checkup by Singlecare

MARCH 8, 2024

The device can be used by people who take medications to help them manage their blood sugar levels —and by people without diabetes who want to monitor how factors such as diet and exercise affect their blood sugar levels. Food and Drug Administration (FDA) approved the first over-the-counter (OTC) continuous glucose monitor (CGM).

FDA 98

FDA Insurance Communication 98

European Pharmaceutical Review

APRIL 7, 2023

A new, sustained-release chemotherapy delivery device inserted into the bladder, facilitated tumour response, a study has reported. The treatment was given to elderly patients with advanced bladder cancer who were medically unfit for standard treatment. Among 14 patients with lasting responses to TAR-200 treatment, 70.5

Chemotherapy 90

Chemotherapy Mayo Clinic 90

The FDA Law Blog

SEPTEMBER 11, 2023

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

Documentation 64

Documentation FDA 64

The FDA Law Blog

APRIL 8, 2024

the focus of the paper turns back to “drug shortages” generally, but HHS acknowledges that “shortages of medical devices have also been an issue for many decades.” HHS suggests that its proposed HRSP “could be expanded to the outpatient setting or to include medical devices.” In Section I.A, surgical robots, MRIs)?

FDA 59

FDA Hospitals Dosage Controlled Substances 59