Legacy MEDSearch

APRIL 27, 2023

(Innoblative), a private medical device company addressing clinical unmet needs for patients with breast cancer, announced that it received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the company’s SIRA RFA Electrosurgical Device (SIRA). For more information, visit Innoblative.com.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

Legacy MEDSearch

MARCH 7, 2023

Food and Drug Administration (FDA). “We are thrilled to receive FDA clearance for the Pro-X1 Trochanteric Nail,” said Brian Thornes, X-Bolt’s founder and inventor of the globally recognized product, TightRope ®. Pro-X1 will be X-Bolt’s flagship launch in the United States. Are you hiring?

FDA 52

FDA Food and Drug Administration Recruitment Distribution 52

Legacy MEDSearch

SEPTEMBER 14, 2023

Beacon Biosignals is thrilled to announce the milestone achievement of FDA 510(k) Clearance for the Dreem 3S, an advanced wearable headband with integrated machine learning algorithms to capture electroencephalogram (EEG) data from the brain to monitor sleep architecture and aid in the diagnosis of disturbed sleep.

FDA 52

FDA Recruitment Medical Patients 52

Legacy MEDSearch

AUGUST 21, 2023

It is the next generation of highly crosslinked polyethylene with vitamin E antioxidant that is intended to further our primary goal of providing immense benefits to our patients.” The first products for Activit-E will launch in the beginning of Q3 2023 for select U.S. Global expansion will begin in 2024. Are you hiring?

Food and Drug Administration 52

Food and Drug Administration FDA Recruitment Marketing 52

Pharmaceutical Technology

MAY 1, 2023

In February this year, the US Food and Drug Administration (FDA) accepted for filing the company’s new drug application (NDA) for Avacincaptad Pegol (ACP) to treat geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Astellas expects that the deal will advance its primary focus on “Blindness & Regeneration”.

Food and Drug Administration 111

Food and Drug Administration Pharma Food Networking 111

Legacy MEDSearch

MAY 24, 2023

In its 510(k) application to the FDA iHealthScreen has proposed the following indication for iPredict’s use: iPredict-AMD is indicated for use by health care providers to automatically detect more than early age-related macular degeneration (mteAMD) in adults above 50 years of age who have not been previously diagnosed with Late AMD (i.e.,

FDA 52

FDA Prospecting Recruitment Healthcare 52

Legacy MEDSearch

SEPTEMBER 6, 2022

Food & Drug Administration (FDA) for the SAINT TM Neuromodulation System for the treatment of major depressive disorder (MDD) in adults who have failed to achieve satisfactory improvement from prior antidepressant medications in the current episode. George, M.D., Magnus Medical, Inc. ,

Medical 52

Medical FDA Food and Drug Administration Recruitment 52

Legacy MEDSearch

JUNE 13, 2023

CorNeat Vision’s EverPatch , a synthetic tissue substitute, has been granted 510(k) clearance by the US Food & Drug Administration (FDA). This groundbreaking synthetic tissue substitute is designed to address the critical needs of ocular surgeons, providing a sterile and non-degradable solution for patients worldwide.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

Legacy MEDSearch

FEBRUARY 3, 2023

a commercial-stage healthcare business dedicated to neonatal intensive care and the acute care hospital community, announced FDA approval of its innovative second generation GENOSYL® Inhaled Nitric Oxide (iNO) delivery system for use with rebreathing anesthesia in the operating room setting. VERO Biotech Inc.,

FDA 52

FDA Food and Drug Administration Recruitment Patients 52

Legacy MEDSearch

JUNE 14, 2023

Food and Drug Administration (FDA) 510(k) clearance for its Pounce LP (Low Profile) Thrombectomy System. By expanding the treatment range of the Pounce platform we are addressing tibial clots, an important component of treatment in this vulnerable patient population which fills a gap in care.” Surmodics, Inc. mm to 6 mm in diameter.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

Legacy MEDSearch

MAY 10, 2023

Food and Drug Administration (FDA) for continuous neonatal and infant monitoring for babies born of any gestational age to infants of 2 years at the International Maternal Newborn Health Conference in Cape Town, South Africa. The vast majority of medical devices used in pediatrics are not FDA-cleared or designed for children.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

Legacy MEDSearch

OCTOBER 13, 2022

Food and Drug Administration (FDA) for the Senza HFX iQ spinal cord stimulation (SCS) system. Senza HFX iQ is the first and only Artificial Intelligence-based SCS system that learns from patients. “Pain is variable from patient to patient and over time. market launch planned for early 2023.

FDA 52

FDA Food and Drug Administration Recruitment Pharmacology 52

European Pharmaceutical Review

AUGUST 31, 2023

Cancer patients critically depend on accurate diagnosis and disease treatment. By reaching cancer cells that have already spread throughout the body, a targeted radiopharmaceutical treatment offers an alternative for patients with advanced cancer when standard lines of treatment, such as chemotherapy, have failed.

Food and Drug Administration 78

Food and Drug Administration Manufacturing Safety Transportation 78

pharmaphorum

DECEMBER 16, 2022

The positive opinion for etranacogene dezaparvovec – which was approved as Hemgenix by the FDA last month – raises the prospect of the first one-time therapy in the EU for the bleeding disorder, which affects around 1 in 50,000 of the population, according to the European Haemophilia Network (EUHANET).

Medicine 116

Medicine Prospecting Networking Marketing 116

Legacy MEDSearch

MARCH 17, 2023

Prompt referral from a PCP to a dermatologist can help minimize patient mortality, morbidity and result in the saving of health care dollars.” Dr. Grant-Kels is the 2023 recipient of the Clarence S. The device was granted FDA Breakthrough Device designation and is currently under review by the FDA. “It

FDA 52

FDA Physicians Recruitment Medical 52

Legacy MEDSearch

MARCH 24, 2023

a company developing a completely transcatheter device-based therapy to address heart failure (HF), announced that patients treated with the investigational AccuCinch ® Ventricular Restoration System demonstrated improvement in HF patient outcomes and beneficial changes in the structure of the heart. Ancora Heart, Inc.,

Patients 52

Patients Recruitment Medical Medicine 52

Legacy MEDSearch

FEBRUARY 24, 2023

SENSORA currently features AI that objectively identifies structural murmurs, a sign of valvular heart disease, and Care Pathway Analytics software that provides downstream visibility and metrics of the patient journey through the healthcare system. We are making the world’s most universal medical exam objective and accurate.”

Physicians 98

Physicians Recruitment Patients FDA 98

European Pharmaceutical Review

JUNE 27, 2023

difficile in December 2022, the microbiome therapies space in 2023 has continued to see revolutionary developments and continued research advancement. Notably, gut microbiome was found to linked to cancer CAR T therapy response, based data from the largest prospective study of its kind, published in Nature Medicine in March 2023.

Food and Drug Administration 98

Food and Drug Administration Manufacturing Medicine Pharma 98

pharmaphorum

JANUARY 5, 2023

Addiction treatment specialist Spero Health has expanded an agreement to use Pear Therapeutics’ prescription digital therapeutics (DTx) in its network of US clinics. We believe having access to patient-reported data via Pear’s clinician dashboard gives us better insight into patient behaviours.”.

Prescription 52

Prescription Specialization FDA Networking 52

European Pharmaceutical Review

JULY 21, 2023

A recent report from the US Food and Drug Administration (FDA) shows that while the number of new drug shortages has fallen significantly from a high of 250 in 2011 to 49 in 2022, there was an increase in new drug shortages year-on-year. Recommendations were also published earlier this year for all stakeholders in the pharma supply chain.

Pharmaceutical 94

Pharmaceutical Food and Drug Administration Transportation Manufacturing 94

Legacy MEDSearch

NOVEMBER 6, 2023

This payment rate supports hospitals and physicians using the non-invasive histotripsy procedure in the outpatient setting to destroy targeted liver tumors while existing Diagnosis Related Group (DRG) payment rates are applicable for patients who require hospital admission.

Recruitment 52

Recruitment Physicians Medical Patients 52

Legacy MEDSearch

JULY 10, 2023

“This submission is another milestone in KORU Medical’s mission to make subcutaneous therapy radically simpler and easier for patients. . “This submission is another milestone in KORU Medical’s mission to make subcutaneous therapy radically simpler and easier for patients.

Medical 40

Medical Food and Drug Administration Recruitment Manufacturing 40

Legacy MEDSearch

FEBRUARY 16, 2023

a developer of medical devices to repair fractures in curved bones, announced the launch of its smaller-diameter, 7.5mm CurvaFix® IM Implant , designed to simplify surgery and provide strong, stable fixation in small-boned patients. patient who sustained a low energy fall two years prior, resulting in pelvic fragility fractures.

Food and Drug Administration 52

Food and Drug Administration Recruitment Patients Medical 52

Clarify Health

OCTOBER 26, 2021

Food and Drug Administration (FDA) released guidance entitled, Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. In fact, 73% were White, 14% were Asian, 6% were Hispanic, and 5% were African American. However, another study found that 0.1% 2] Figure 1.

Food and Drug Administration 52

Food and Drug Administration Recruitment Pharmaceutical manufacturing Medical 52

PM360

NOVEMBER 12, 2023

Macroeconomic Factors The pandemic really changed the game, driven by several disruptions that changed physician and patient behavior forever. Long patient journeys, seen in many rare diseases and oncologic tumors, were disrupted enough that it will take years to catch up. of claims for care were via telemedicine.

Physicians 64

Physicians Marketing Sales Pharma 64

Legacy MEDSearch

SEPTEMBER 20, 2023

a medical imaging company focused on improving the treatment and outcomes for patients with coronary artery disease (CAD), today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for product enhancements to the HyperVue Imaging System. Intravascular imaging is essential to optimize patient outcomes,“ said Richard A.

Food and Drug Administration 52

Food and Drug Administration Recruitment Physicians Patients 52

Legacy MEDSearch

JUNE 27, 2022

Centerline Biomedical’s system improves visualization and guidance in endovascular procedures while reducing dependence on radiation and contrast agents with the goal of improving patient outcomes, as well as overall efficiency for clinicians. IOPS® is FDA 510(k) cleared and currently launching in the US at select sites.

Recruitment 52

Recruitment Healthcare Healthcare Safety 52

PM360

DECEMBER 20, 2023

At the close of Q3 2023, the SPDR S&P Biotech ETF (XBI), which tracks small and mid-size biotechs, was down 12% compared to the previous year while the S&P 500, an index tracking the stock performance of 500 of the largest companies in the U.S. per patient on life-long standard of care. and 10X Capital Venture Acquisition Corp.

Management 109

Management Marketing Healthcare Healthcare 109

Nixon Gwilt Law

SEPTEMBER 7, 2023

Stricter privacy rules apply Healthcare data privacy standards are already complex under the Health Insurance Portability and Accountability Act (“HIPAA”), but several additional regulations come into play when working with patients under 18. California Medicaid, however, only covers RPM for patients 21 and older, excluding children entirely.

Food and Drug Administration 52

Food and Drug Administration Education Insurance Healthcare 52

Legacy MEDSearch

JUNE 16, 2023

The study permits surgeons to select the investigational device—the pro disc C Vivo and/or pro disc C SK —based on the patient’s anatomy, as well as other surgical factors. I’ve found that pro disc C Vivo and pro disc C SK provide a powerful means to customize my surgical treatment to each patient.”

Food and Drug Administration 52

Food and Drug Administration Recruitment Safety Medical 52

Legacy MEDSearch

SEPTEMBER 6, 2023

The transaction is subject to customary closing conditions and is expected to close in the third quarter of 2023. One where innovators are responsible for creating simple tools that fit into patients’ lives, not the other way around. Financial terms were not disclosed.

Healthcare Provider 52

Healthcare Provider Recruitment Healthcare Healthcare 52

Legacy MEDSearch

MARCH 3, 2023

Dr. Salerno will scan a patient at Stanford Health in Palo Alto, Calif., CST on March 5, 2023. A case study summarizing Dr. Kwong’s previously released clinical findings, including data from the first six months and 1,100 patients, is available at vista.ai/evidence/studies. virtually from the ACC.23/WCC evidence/studies.

Recruitment 52

Recruitment Training Patients Specialization 52

PM360

OCTOBER 25, 2023

Food and Drug Administration (FDA) oncology approvals were for drugs used in combination. 1 Between 2022 and 2023, 47% of Phase III oncology trials involved combination therapies, a number that continues to grow over time (see Figure 1). JAMA Network Open 5 , no. Between May 1, 2016, and May 31, 2021, 42% of all U.S. 2022.2265.

Food and Drug Administration 105

Food and Drug Administration Manufacturing Marketing Pharmaceutical manufacturing 105

PM360

AUGUST 9, 2022

How can we help ensure patients continue to take their medications as prescribed? The reasons why a patient may not take their medication are plentiful, and as a result so are the solutions now available to attempt to solve this issue. But it is not a simple answer. Furthermore, it is estimated to reach $6.5

Prescription 105

Prescription Medical Side effects Patients 105

Nixon Gwilt Law

DECEMBER 16, 2021

We also speak, network, and learn at various conferences throughout the year. Rounding it all out is our podcast on the Slice of Healthcare network called Decoding Healthcare Innovation. So much so that we’ve recently welcomed 20-year Food and Drug Law veteran and FDA expert Mark Mansour, Esq.,

Healthcare 52

Healthcare Healthcare Food and Drug Administration Ethics 52

Pharmaceutical Technology

JANUARY 10, 2023

On November 17, 2022, the FDA approved Provention Bio’s Tzield (teplizumab) , making it the first and only treatment to delay the onset of type 1 diabetes (T1D). The international T1D network TrialNet’s research was instrumental in the FDA’s approval of the first drug to delay T1D in at-risk people.

Patients 98

Patients FDA Medicine Education 98

Legacy MEDSearch

DECEMBER 21, 2022

a groundbreaking respiratory support technology company, announced today that it has begun the manufacturing process for the ALICE CPB (Cardiopulmonary Bypass) device (the “ALICE device”) to undergo the Verification and Validation phase prior to its planned 2023 submission to the U.S. Press Release by: Inspira Technologies.

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